Compositions Comprising Dietary Fat Complexer and Methods for Their Use

ABSTRACT

This invention relates to fat containing consumable food products comprising α-cyclodextrin. The food products have reduced levels of bioavailable fat but have substantially the same fat, cholesterol and caloric content as a like food without α-cyclodextrin. The invention also relates to methods for reducing the bioavailability of fats in fat containing food products without reducing caloric intake as determined by bomb calorimetry and to methods for increasing high density lipoproteins in a subject and reducing or controlling weight by administering the food products of this invention.

This application is a divisional of U.S. application Ser. No.10/923,000, filed Aug. 23, 2004, which is a continuation of U.S.application Ser. No. 10/628,475, filed Jul. 29, 2003, now U.S. Pat. No.6,890,549, which claims priority to U.S. provisional patent applicationSer. No. 60/486,440 filed Jul. 14, 2003, Ser. No. 60/461,847 filed Apr.11, 2003, and Ser. No. 60/404,366 filed Aug. 19, 2002, all incorporatedherein in their entirety by reference.

FIELD OF THE INVENTION

This invention relates to consumable products, particularlyfat-containing consumable products, comprising α-cyclodextrin andmethods of their use. The invention also relates to methods of reducingthe bioavailability of fats in fat containing consumable products and tomethods for enhancing organoleptic properties of fat containingconsumable products.

BACKGROUND OF THE INVENTION

Efforts to control body weight through diet, exercise and drugs have metwith only limited success. Obesity continues to be of epidemicproportions in the USA. It was estimated that in 2000, more than 64.5%of the US adult population were overweight or obese and across the US,30.5% of the population were obese (Flegal et al., JAMA 288: 1723-1727(2002)). There also appears to be a US epidemic in diabetes with 7.3% ofthe US population being diabetic (Mokdad et al., JAMA 286: 1195-1200(2001)). While physicians advise their patients battling with weightgain, obesity and diabetes to exercise and manage the quantity as wellas the quality of food eaten, the evidence suggests that a major portionof the population are unable or unwilling to make the major changes inlifestyle that may be necessary to decrease their body mass.

The strategies recommended by health care providers to reduce and/ormaintain weight often involve changes in life style and in some casesthe additional use of drugs or dietary supplements. Those individualsthat are able to maintain weight loss (defined as >10% below the initialbody weight after one year) generally adopt all or at least somecombination of these strategies (McGuire et al., “Behavioral strategiesof individual who have maintained long-term weight losses” Obes Res7:334-341 (1999)). Nonetheless, despite all of the efforts made by obeseindividuals and governments, the success rate for keeping weight off isdisappointingly low. A meta-analysis has shown that the success rate of“self-cure” ranged from 9% to 43% after a one-year follow-up (Bartlettet al., “Is the prevalence of successful weight loss and maintenancehigher in the general community than the research clinic?” Obes Res7:407-413 (1999)). The National Weight Control Registry has reportedthat 47%-49% of the obese patients maintained at least 10% weight lossafter one year and 25%-27% have maintained this amount of weight lossover 5 years (McGuire et al., “The prevalence of weight loss maintenanceamong American adults” Int. J Obes Metab Disord 23:1314-1319 (1999)).However, after 5-15 years, only 5% of the obese patients were able tomaintain the weight loss (Drenick and Johnson, “Weight reduction byfasting and semistarvation in morbid obesity: long term follow-up”. Int.J. Obes. 2:25-34 (1978) and Sarlio-Lahteenkorva and Rissanen “Adescriptive study of weight loss maintenance: 6 and 15 years follow-upof initially overweight adults” Int J Obes 24:116-125 (2000)).

Pharmaceutical treatments for obesity have been developed but their usehas limitations. Currently there are only two Food and DrugAdministration (FDA) approved antiobesity drugs, Orlistat andSibutramine. Orlistat inhibits pancreatic lipase activity in the smallintestine. Pancreatic lipase breaks down triglycerides into fatty acidsand monoglycerides which are subsequently absorbed into the body. Thusinhibition of lipase activity effectively reduces fat absorption.However, if the patient fails to follow a reduced fat diet, which isrecommended while on this medication, the fat is metabolized by theintestinal bacteria and causes osmotic shifts and gas productionresulting in diarrhea and flatulence, rather unpleasant side effects ofthis medication. Thus, while this drug can induce modest weight loss andbetter weight maintenance than diet alone, in the absence of major‘dietary changes the adverse effects of gastrointestinal discomfort,diarrhea and flatulence have limited its use (Heck et al., “Orlistat, anew lipase inhibitor for the management of obesity”. Pharmacotherapy20:270-279 (2000)).

Sibutramine is a serotonin and norepinephrine reuptake inhibitor andreduces body weight by suppressing appetite (Bray G., “Drug treatment ofobesity”. Rev Endocr Metab Disord 2:403-418 (2001)). FDA has approved itfor the treatment of obesity for up to 2 years. However, Sibutramineinhibits the reuptake of norepinephrine and thus may increase bloodpressure. Therefore this drug is contraindicated for use in some obesepatients (Bray 2001 supra and Sramek et al. “Efficacy and safety ofsibutramine for weight loss in obese patients with hypertension wellcontrolled by beta-adrenergic blocking agents: a placebo-controlled,double-blind, randomized trial” J Hum Hypertens 16:13-19 (2002)). Otherside effects of Sibutramine include increased heart rate, insomnia,constipation, headache, abdominal pain etc. For normotensive obesepatients, Sibutramine in combination of diet and behavioralmodifications has shown beneficial effects (Astrup and Toubro “When, forwhom and how to use sibutramine?” Int J Obes Relat Metab Disord 25(suppl 4):S2-S7 (2001)) but to date there have been no human studiesthat used Sibutramine alone, that is without any life-stylemodifications. In addition, in one animal study, the appetitesuppressing effects of Sibutramine gradually attenuated over severaldays of administration (Strack et al. “Regulation of body weight andcarcass composition by sibutramine in rats” Obes Res 10:173-181 (2002)).

Dietary supplements have also been used to reduce weight gain, tomaintain weight and to treat some of the metabolic abnormalitiesassociated with obesity. For example, omega 3-fatty acids and linolenicacid have been shown to reduce weight gain and affect triglyceridelevels and/or insulin resistance. Omega 3 fatty acids are known toreduce blood lipid levels in normal, hyperlipidemic and diabetic humansand have been reported to decrease body weight. Diabetic patientswithout hyperlipidemia fed a diet comprising fish oil, which is known tobe high in omega 3 fatty acid, did not display reduced blood lipidlevels, although their blood pressures were reduced. However, diabeticpatients having hyperlipidemia had significantly reduced bloodtriglyceride levels and reduced blood pressure after the omega 3 fattyacid fish oil feeding (Kasmin et al. J. Clin Endocrinol Metab 67:1-5(1988)). The effect of diets comprising fish oil fed to geneticallyobese Zucker rats and their lean counterparts demonstrated that both theobese and normal rats had a reduction in body weight and blood lipidlevels as compared to controls (Jen et al., Nutrition Research9:12171228 (1989)). A high fat diet made with fish oil induced the leastamount of weight gain and insulin resistance compared to a high fat dietmade with other types of oil (Pellizzon et al., Obesity Res. 10:947-955(2002)) Omega 3 fatty acids also appear to beneficially affect insulinresistance. Rats fed high fat diets comprising fish oil had less insulinresistance than rats fed diets comprising other oils, e.g., lard, cornoil or medium chain triglycerides (Hill et al. Int. J. Obesity,17:223-236 (1993)).

Linolenic acid added to diets has also been shown to reduce body fatcontent and to facilitate fatty acid β-oxidation in the liver (Takada etal., J. Nutr. 124:469-474 (1994)). Aged rats were fed diets made withvarious fatty acids, i.e., α-linolenic acid (n-3 PUFA) or gammalinolenic acid (n-6 PUFA) (10% w/w) with added cholesterol for 15 weeksand it was found that both the α- and gamma linolenic diets inhibitedthe increase in blood total cholesterol, VLDL-+-IDL+LDL cholesterollevels in the rats when fed high cholesterol diets (Fukushima et al.Lipids 36:261-266 (2001)). Similar results were found in obese Zuckerrats which had reduced body weight gain and body fat when gavaged dailywith gamma linolenic acid (Phinney et al. Metabolism 42:1127-1140(1993)). In humans, a mixture of n-3 PUFA and gamma linolenic acid alsofavorably altered blood lipids and fatty acid profiles in women afteradministration for about 28 days (Laidlaw and Holub, Am J. Clin. Nutr.77:37-42 (2003)).

Life style changes to promote weight loss and other beneficial healtheffects include, e.g. an increase in physical activity; a reducedcaloric intake and a reduced dietary fat intake. The United States hasseen a gradual reduction in the percentage of dietary fat intake from43.7% in 1965 to 33.1% in 1995 (Kennedy et al., “Dietary-fat intake inthe US population” J Am Coll Nutr 18:207-212 (1999)), however, theaverage number of calories eaten has increased more than the increase infat consumption. Therefore even though the percentage of dietary fatintake has decreased, the total fat intake has increased since 1995 to100.6 g (males). Due to the relative ease with which dietary fat isconverted to adipose tissue, a diet high in fat leads to an elevatedweight gain as compared to a lower fat diet even though the calorieintake is comparable. This phenomenon has been reported to occur in bothhumans and rats (Astrup et al, “Obesity as an adaptation to a high-fatdiet: evidence from a cross-sectional study” Am J Clin Nutr; 59:350-355(1994)); (Jen “Effects of diet composition on food intake and carcasscomposition in rats” Physiol Behav 42:551-556 (1988) and; Jen et al.,“Long-term weight cycling reduces body weight and fat free mass, but notfat mass in female Wistar rats” Int J Obesity 19:699-708 (1995)).

Various low fat and/or low calorie foods have been developed in aneffort to promote weight loss or inhibit weight gain. Many “low fat”foods are prepared by reducing the percentage of fat but the percentageof carbohydrates in the foods is increased to make the foods morepalatable by compensating for the loss of the “taste and textureprovided by the fat. Increasing the amount of carbohydrates, e.g.,sugars, in the food often make the foods “low fat” but the caloriccontent may not be reduced and in many instances is actually increased.Many low calorie food are prepared by simply replacing the caloriccomponents of the food with a non-caloric filler, e.g., a dietary fiber.However, replacing significant portions of carbohydrates with fiberfillers often alters the taste and texture of the food making the foodless palatable for some consumers. In addition, consumption of largeamounts of dietary fiber often have unwanted side effects such as e.g.,flatulence, and a diet comprising more than about 60 g fiber may resultin deficiencies in calcium, iron, zinc and increased risk of bowelobstruction. While high fiber diets, comprising about 25-35 g/d arerecognized as having beneficial effects, e.g., reducing bloodtriglycerides and cholesterol levels, many persons should not take highlevels of fiber, e.g., the elderly, growing children and those sufferingfrom particular medical conditions e.g., acute or subacutediverticulitis, and the acute phases of certain inflammatory conditionsof the bowel, e.g., ulcerative colitis or Crohn's disease. After sometypes of intestinal surgery, e.g., a colostomy or ileostomy, a lowfiber, low residue diet is used as a transition to a regular diet ispreferred. Thus it is desirable to develop a food product that has thetaste and texture desired by consumers but also reduces weight gain,blood triglycerides and cholesterol levels and is not necessarily highfiber.

Cyclodextrins are a family of cyclic polymers of glucose produced byenzymatic digestion of cornstarch with a cyclodextringlyceryltransferase. α-, β- and γ-cyclodextrins contain 6, 7 and 8glucose molecules and take on a toroid or truncated cone conformation inaqueous solution. The molecules have a hydrophobic interior andhydrophilic exterior forming an internal pore. The different polymerlengths yield different pore sizes.

The unique properties of β and γ-cyclodextrins have been exploited in avariety of fields. For example, they have been used to stabilize andsolubilize drugs and also to enhance food flavors. While the β andγ-cyclodextrins have found considerable use in the pharmaceutical andfood industries, α-cyclodextrin has found relatively little use in theseindustries because of its small pore size as well as the fact that itdoes not appear to be metabolized by pancreatic amylase or intestinalflora (Suzuki and Sato, “Nutritional significance of cyclodextrins:indigestibility and hypolipemic effect of α-cyclodextrin” J Nutr SciVitaminol (Tokyo) 1985; 31:209-223), although this latter aspect hasbeen disputed by one of the manufacturers of the material (Antlsperger GSG. “Toxicological comparison of cyclodextrins” presented in the 8thInternational Cyclodextrin Symposium in Budapest 1996:1-7).α-cyclodextrin efficiently complexes free fatty acids (FFA) in solution(McGowan et al. “A peroxidase-coupled method for the colorimetricdetermination of serum triglycerides” Clin. Chem. 29(3):538-542 (1983))and has been used to eliminate the turbidity caused by FFA in a numberof clinical diagnostic reagents (Morgan, Artiss and Zak “A study ofturbidity in hypertriglyceridemic specimens” Microchem. J. 64:147-154(2000)). α-cyclodextrin has also been used for the specific andselective removal of free fatty acids from used cooking oil (U.S. Pat.No. 5,560,950).

Previous studies disclose that α-cyclodextrin is essentiallyindigestible and may exert an effect on weight gain only if it exceedsabout 20% of the total dietary intake, as determined in a rat model.Japanese patent application JP 05-298849 (Publ. No. 07115934) assays theeffects of linolenic acid and α-cyclodextrin on weight gain in rats.This application reports that rats fed diets comprising either 16%α-cyclodextrin or 1% linolenic acid gain weight approximately the sameas rats fed a control diet. In contrast, this Japanese applicationdiscloses that rats fed diets comprising a combination of 14%α-cyclodextrin and 2% linolenic acid incur significant weight loss.Japanese patent application S60-149752 also analyzes the effect oflinolenic acid in combination with α-cyclodextrin on weight gain inrats. This application reports that a diet comprising 14% w/wα-cyclodextrin has little effect on weight gain in rats while thecombination of 14% w/w α-cyclodextrin and 0.5% w/w linolenic acidproduces significant weight loss. Japanese patent application H5-298850analyzes the effects of diets comprising linolenic acid (1.5-2% w/w) andα-cyclodextrin (14% w/w) and a barley green element. This applicationreports that the diets comprising 14% w/w α-cyclodextrin in combinationwith 1.5-2% w/w linolenic acid produce only small decrease in bodyweight while the addition of a barley green element to the linolenicacid and cyclodextrin results in significant reduction in weight gain.This application does not report the effects of diets. comprising onlyα-cyclodextrin as the additional component. None of these applicationsdiscloses the fat content of the diets and they teach the importance ofadditional ingredients and/or the ineffectiveness of α-cyclodextrinalone.

Japanese patent application H4-333575 supplemented the diet of rats withparticular total amounts of linolenic acid and/or α-cyclodextrin and/ora peptide hydolysate by gavaging rats with wheat starch compositionscomprising either 0.9% w/w linolenic acid alone, 9% w/w α-cyclodextrinalone, or 100% w/w of a compositions of small molecular weighthydrolytes of a larger molecular weight protein, or with compositionscomprising combinations of the three components. The fat content of thediets was not described. Only the diets containing a combination oflinolenic acid, α-cyclodextrin and the peptide hydrolysate displayed asignificant change in the rate of weight gain over time.

Japanese applications JP05-113603 (Publ. No. 08187060) and JP05-164024(Publ. No. 06343419) assay the effect of a mixture of about 15%α-cyclodextrin and 1.5% linolenic acid on weight gain in humans. Theapplications disclose that subjects ingesting theα-cyclodextrin/linolenic acid compositions in an amount based on theirbody weight, such that the daily dose of the composition was about 0.015g/kg body weight three times a day, which is 1.37 g/91 kg (200 lb)individual three times per day, which corresponds to 4.11 g of totalcomposition per day or 0.62 g α-cyclodextrin per day (0.21 g/meal) and0.068 g linolenic acid per day (0.023 g/meal), display a significantincrease in weight loss as compared to subjects who did not ingest thecombination. However, these applications did not assay the effect ofα-cyclodextrin alone or linolenic acid alone nor did they disclose thefat content of the diets. Linolenic acid is well known to reduce weightand fat gain in both animal and human studies (Jen et al., Nutri. Res9:1217-1228 (1989) and Takada et al., J. Nutri. 124:469-474 (1994) andCouet et al. Int. J. Obes. 21:637-643 (1997)) and is likely to be thecomponent that actually promoted the observed weight loss reported inthese applications.

U.S. Pat. No. 4,880,573 discloses a process for eliminating cholesterolfrom fatty substances of animal origin, e.g. lard, suet or butter. Theprocess combines β-cyclodextrin with the liquified fatty substance undera non-oxidizing atmosphere and then removes the complexes of cholesteroland cyclodextrin leaving a fatty substance free of cyclodextrin and witha reduced cholesterol content.

U.S. Pat. No. 5,189,149 discloses the use of complexes of cyclodextrinsand long chain fatty acids, their salts and esters, inclusive of fishand vegetable oil glycerides, to deliver long chain fatty acids to asubject and avoid the unctuous characteristics associated with the fishand vegetable oil glycerides and their unpleasant taste and odor.

U.S. Pat. No. 5,232,725 relates to a process for reducing thecholesterol and free fatty acids in a fat containing material, e.g.,fresh cream, by combining water, the fat containing material andcyclodextrin under conditions suitable for forming an oil-in-water type“fine” emulsion, which facilitates the formation of complexes ofcyclodextrin and cholesterol or free fatty acids. The complexes are thenmechanically separated to produce a fat-containing material with reducedlevels of cholesterol and free fatty acids. U.S. Pat. No. 5,232,725 doesnot describe a food product comprising complexes of triglyceride andα-cyclodextrin, wherein the bioavailability of the fat in the foodproduct is reduced, as described herein.

U.S. Pat. No. 5,560,950 relates to a process for reducing the free fattyacid content of a used oil by mixing the used oil with cyclodextrin,preferably with an absorbent, e.g., silica, under conditions that formagglomerates of cyclodextrin absorbent and fatty acids and then removingthe cyclodextrin agglomerates from the oil. The process produces a oilthat is cyclodextrin free and has a reduced level of free fatty acids.

U.S. Pat. No. 5,571,554 relates to a process for reducing triglyceridesin an egg yolk by preparing a mixture of egg yolk with water, or a saltsolution, and combining the mixture with a cyclodextrin and thenremoving the cyclodextrin and the added water or salt solution. Theprocess produces a cyclodextrin free egg yolk product with reducedlevels of triglycerides.

U.S. Pat. No. 5,738,898 relates to a process for reducing cholesterol inegg yolk by preparing a mixture of egg yolk, water and cyclodextrin at apH between 7.5 and 12. The cyclodextrin cholesterol complexes areremoved and the pH adjusted to pH 6-7. The process produces acyclodextrin free egg yolk product with reduced cholesterol.

Many consumers, including obese individuals, appear to have a preferencefor foods that have a high fat content (Mela and Sacchetti, “Sensorypreferences for fats: relationships with diet and body composition” Am0.1 Clin Nutr 1991; 53:908-915). Thus, it is very difficult for manyindividuals, particularly obese individuals, to reduce their fat intakein order to reduce their body weight and the adverse health effectsassociated with increased weight gain. Therefore, a substance thatreduces the absorption of dietary fat without the unpleasant sideeffects of the current medications is extremely desirable. Such asubstance would have significant health benefits in reducing obesity andits related disorders, such as Type II diabetes (NIDDM). It would bedesirable to develop a food product that promotes weight loss, reduceslipid levels and reduces the symptoms of other disorders associated withweight gain/obesity and yet has desirable organoleptic properties.Described herein are fat containing consumable products having theorganoleptic properties such as taste, texture and moistness thatconsumers desire and yet promote weight loss and other health benefits.

SUMMARY OF THE INVENTION

This invention relates to a fat containing consumable food product thatcomprises α-cyclodextrin and fat wherein the ratio of α-cyclodextrin tofat is about 1:20 w/w-1:3 w/w. Preferably the ratio of α-cyclodextrin tofat is about 1:13 w/w-1:5 w/w, and most preferably the ratio ofα-cyclodextrin to fat is about 1:9 w/w. The total cyclodextrin in thefoods of this invention is less than about 9-10% w/w, preferably lessthan about 6%, and more preferably below 3% w/w, and particularly in thecase of fat containing consumable farinaceous food products of thisinvention the amount of total cyclodextrin is below about 3% w/w.Preferably the fat containing food products of this invention comprise,by caloric content, about 7% to about 80% fat, preferably about 20% toabout 70% fat, more preferably about 40% to about 70% fat, or by weight,5% to about 50% w/w fat, preferably about 5-30% w/w fat, and morepreferably about 7-25% w/w fat. “Fats” as defined herein aretriglycerides. Cyclodextrins are often sold as mixtures of a, β-,γ-cyclodextrin and n-dextrin. Preferably the α-cyclodextrin compositionthat may be used in the products and methods of this invention, is asubstantially pure α-cyclodextrin comprising at least about 95%α-cyclodextrin, preferably at least 98% α-cyclodextrin.- Theα-cyclodextrin in the foods herein may provide a source of fiber inaddition to its other beneficial effects. The consumable products may bea farinaceous food product or a non-farinaceous food product, e.g., adairy food product, a prepared vegetable product, or a prepared meatproduct, e.g. a prepared beef, lamb, pork, poultry or seafood foodproduct. The consumable food products of this invention are suitable forconsumption by mammals, e.g., mice, rats, cats, dogs and humans butpreferably humans.

Cyclodextrins have been used previously in methods to reduce the levelsof free fatty acids, cholesterol or triglycerides in food products butin contrast to the food products of this invention, those methodsproduced products that are essentially cyclodextrin free and havereduced levels of free fatty acids, cholesterol and triglycerides ascompared to a like food product that has not been treated. If assayed bybomb calorimetry, the products produced by those methods will have alower caloric content due to the reduced levels of cholesterol andtriglycerides. The consumable food products of this invention compriseα-cyclodextrin and do not have reduced levels of fatty acids,cholesterol or triglycerides as compared to a like food product withoutthe added α-cyclodextrin. As such, the consumable products of thisinvention do not have a substantially reduced caloric content, asassayed by bomb calorimetry, as compared to a like product that does notcontain α-cyclodextrin, and yet the food products of this inventioninhibit the rate of weight gain, promote weight loss and provide otherhealth benefits. Thus the consumable food product of this invention is adiet food that inhibits the rate of weight gain, promotes weight lossand provides other health benefits.

Shimada et al. (Shimada et al. “Structure of inclusion complexes ofcyclodextrins with triglyceride at vegetable oil/water interface” J.Food Sci. 1992; 57(3):655-656) reported that two molecules ofα-cyclodextrin complex with one fatty acid group (FFA), while Szejtli(Szejtli J. “Utilization of cyclodextrins in industrial products andprocesses” J. Mater. Chem. 1997; 7:575-587) suggests that thisphenomenon is dependent upon the chain length of the fatty acids andthat it is possible for 3-4 molecules of α-cyclodextrin to complex witheach of the three fatty acids of a triglyceride molecule, which suggests9-12 molecules of α-cyclodextrin would be required to completely complexone molecule of triglyceride. If this were the case it would bedifficult to imagine being able to feed enough α-cyclodextrin to ananimal to complex sufficient amounts of triglycerides to make asignificant difference in body weight.

Suzuki et al. infra and Kaewprasert et al. infra both report that acyclodextrin composition alone mixed into a food does not promotesignificant weight loss, even at concentrations of 20% w/w of totaldietary intake. In particular, Suzuki et al., Denpun Kagaku30(2):240-246 (1983) analyzed the effect of a diet comprising 20%cyclodextrin on the weight gain of rats and reported that there were nodifferences in the weight gain of rats fed a 20% cyclodextrin diet andthose fed a 20% starch diet. Likewise, Kaewprasert et al., J. Nutri.Sci. Vitaminol. 47:335-339 (2001) reported that the body weight gain inrats fed a 5% α-cyclodextrin diet was not significantly different fromrats fed control diets. Kaewprasert discloses a diet comprisingcyclodextrin and fat at a ratio of about 1:1.4. Suzuki did not discussthe fat content of the experimental diets or disclose the ratio ofcyclodextrin to fat in the diet. This effect of relatively large amountsof cyclodextrin was also noted in Japanese application S60-094912.S60-094912 suggests that cyclodextrins may inhibit the rate of weightgain and decrease neutral fat (triacylglycerides) in liver and plasma,but only if cylodextrin is administered at levels of 20% w/w and more.Likewise Suzuki and Sato, J. Nutri. Sci. Vitaminol. 31:209-223 (1985)report that rats fed diets comprising a mixture of n-dextrin and α-, β-and γ-cyclodextrins (50:30:15:5% w/w) displayed a weight losssubstantially different from the control group only when at least 58.5%w/w of the diet consisted of the cyclodextrin mixture. In contrast, wehave found that significant weight loss can be obtained in subjects withmuch lower levels of α-cyclodextrin if the subjects are consuming fatcontaining diets and the ratio of ingested α-cyclodextrin to ingestedfat in the diet is sufficient to form complexes of fat and cyclodextrin.The body naturally forms a fine emulsion of fat in water, which isnecessary for lipase to catalyze the hydrolysis of fat. Without wishingto be bound by theory, the invention described herein disrupts thisprocess by forming large complexes of α-cyclodextrin and fat so that thelipase cannot act on the fat. Thus the fat in the fat containing foodproducts of this invention is not bioavailable because it is in the formof α-cyclodextrin/fat complexes that are resistant to lipase activity.

The levels of cyclodextrin in the foods of this invention are well belowthe levels that S60-94912 and Suzuki and Sato (J Nutri Sci Vitaminol1985 supra) indicate are necessary for weight loss. The totalcyclodextrin in the foods of this invention is less than about 9% w/w,preferably less than about 6% w/w, and more preferably below 3% w/w,particularly in the case of the consumable farinaceous food products ofthis invention. Subjects fed .a diet comprising theα-cyclodextrin-containing foods of this invention, preferably thosewhich comprise the amounts of α-cyclodextrin disclosed herein andwherein the α-cyclodextrin to fat ratio is within the ratios disclosedherein, display inter alia weight loss, increase in HDL levels and areduction in blood triglycerides.

Without wishing to be bound by theory, the results presented hereinsuggest that the α-cyclodextrin is particularly suitable for complexingfat in a food composition thereby reducing the fat's bioavailability. Byingesting α-cyclodextrin in an appropriate amount with a fat-containingmeal, or shortly before or after ingesting a fat-containing meal, asubject may complex the ingested fat and inhibit its absorption by thebody. The amount of α-cyclodextrin should be sufficient to formcomplexes with the fat thereby reducing the fat bioavaibility,preferably the amount of α-cyclodextrin is sufficient to obtain a ratioof α-cyclodextrin to fat of 1:20 to 1:3, preferably 1:13 to 1:5 and morepreferably about 1:9 such that complexes of fat and cyclodextrin areformed. Without wishing to be bound by theory, it is the reduction inthe bioavailability of the ingested fat (the amount of ingested fat thatis absorbed and thus available to the body for use) that results in,e.g., the observed weight loss, increase in HDL cholesterol, decreasedleptin levels and reduction in serum triglycerides.

This invention also relates to methods for complexing fat contained inan ingested food product, particularly a high fat food product, thusreducing the bioavailability of the ingested fat. The method comprisesingesting an amount of an α-cyclodextrin with a food product such thatthe ratio of α-cyclodextrin to fat of about 1:20 to about 1:3 w/wpreferably about 1:13 to about 1:5 w/w most preferably about 1:9 w/w.The α-cyclodextrin may be ingested prior to, concurrently with orsubsequent to ingestion of the food product. At such ratios the fat iscomplexed with the α-cyclodextrin and the bioavailability of theingested fat is reduced. Alternatively the α-cyclodextrin my be combinedwith the food product prior to consumption in an amount such the ratioof α-cyclodextrin to fat in the ingested food product is about 1:20 toabout 1:3 w/w preferably about 1:13 to about 1:5 w/w most preferablyabout 1:9 w/w and the food product comprising the α-cyclodextrin and fatis ingested.

This invention also relates to methods for producing a fat containingfood product having fat with reduced bioavailability by formingcomplexes of α-cyclodextrin and fat within the food product,particularly a high fat food product. The method comprises combiningα-cyclodextrin with a food product under conditions that favor theformation of complexes of fat and α-cyclodextrin, wherein the conditionsavoid the formation of a fine emulsion of fat within• the food product.The amount of an α-cyclodextrin is such that the food product comprisesa ratio of α-cyclodextrin to fat of about 1:20 to about 1:3 w/wpreferably about 1:13 to about 1:5 w/w most preferably about 1:9 w/w. Atsuch ratios and under such conditions, the fat is complexed with thecc-cyclodextrin the bioavailability of the ingested fat is reduced. Thefood product may be a farinaceous food product e.g., snack bars,breakfast cereals, pancakes, waffles, muffins, fruit filled pastries,tortillas, corn chips, tortilla chips, snack crackers, breads, cakes,cookies, or pies, or non-farinaceous food product, e.g, a vegetable,dairy, or meat food product e.g. french fries, tempura, veggie burgers,refried beans, hummus, tahini, margarine and nut butters, (e.g., peanut,cashew, almond, hazelnut), marzipan, potato chips; milk, cream, pudding,butter, ice cream, and cheese and processed cheese products, preparedbeef, lamb, pork, poultry or seafood products, e.g., frankfurters, delislices, sausages, fish sticks, chicken fingers, and ground meats, e.g.,meatloaf, meatballs and hamburgers, yogurt and yogurt products, and eggproducts.

Thus this invention also relates to a method for promoting weight lossor inhibiting weight gain in a subject comprising administering to asubject in need thereof α-cyclodextrin in an amount and for a timesufficient to produce a weight loss or inhibit weight gain. Preferablythe α-cyclodextrin is administered to a subject consuming an average fatdiet (about 100 g fat/day, about 33 g fat/meal) wherein the amountadministered to the subject is such that the ratio of α-cyclodextrin tofat ingested per meal, or daily, by the subject is about 1:20 to about1:3 w/w, preferably the ratio is about 1:13 to about 1:5 w/w and morepreferably about 1:9 w/w. Once the desired weight is lost, theα-cyclodextrin may be included in the diet in an amount to inhibit orpreferably prevent weight gain. For a loss of about 1-1.5 lbs per weekfor a subject whose dietary intake is 100 g fat/day (about 33 gfat/meal), the amount of α-cyclodextrin administered is preferably about2 g/meal, thus reducing the bioavailability of approximately 54 g of fatper day.

Serum cholesterol is found in combination with proteins in the blood. Ofparticular interest are high density (HDL the good cholesterol) and lowdensity lipoprotein (LDLs the bad cholesterol). This invention relatesto a method for increasing the level of high density lipoprotein (HDL)in a subject comprising administering α-cyclodextrin to a subject inneed thereof in an amount and for a time sufficient to increase HDLlevels. Preferably the amount α-cyclodextrin administered to the subjectis about four to about eleven grams per day. Preferably, theα-cyclodextrin is administered in an amount such that the ratio ofα-cyclodextrin to fat ingested per meal, or daily, is about 1:20 to 1:3w/w more preferably 1:131:5 w/w or most preferably about 1:9w/w. Theα-cyclodextrin may be administered in a variety of forms, e.g., atablet, capsule, pill, elixir, wafer, beverage, or in a food product,e.g., bread products, e.g., buns, rolls, biscuits, and breakfastcereals, e.g., oatmeal, cream of wheat, raisin bran, corn flakes, orother ready to eat cereals, meat products and dairy products, andparticularly the consumable food products of this invention. Preferablythe tablet, pill, capsule, elixir, wafer, beverage, or the consumablefood products comprises a cyclodextrin that is predominantlyα-cyclodextrin, e.g., the cyclodextrin is at least, about 90-98%α-cyclodextrin.

It is possible that the total levels of cholesterol in the blood willremain constant even though the levels of HDL are elevated if there is areduction in the levels of LDL. Preferably the total cholesterol levelsare substantially reduced or are unchanged by the methods of thisinvention. Thus, this invention also relates to a method for reducingthe cholesterol/HDL ratio in a subject comprising administering to asubject in need thereof α-cyclodextrin in an amount and for a timesufficient to reduce the cholesterol/HDL ratio, The α-cyclodextrin maybe administered in a variety of forms, e.g., a tablet, pill, capsule,elixir, wafer, beverage, or in food products, e.g., bread products,e.g., buns, rolls, biscuits, and breakfast cereal, e.g., oatmeal, creamof wheat, raisin bran, corn flakes, or other ready to eat cereal, andparticularly the consumable food products of this invention. The tablet,pill, capsule, elixir, wafer, beverage, or food products may containα-cyclodextrin in combination with other cyclodextrins, e.g. β and/or γcyclodextrins or with n-dextrin. Preferably the cyclodextrin in thetablet, pill, capsule, elixir, wafer, beverage, or the food products ispredominantly α-cyclodextrin, e.g., the cyclodextrin is at least about90-98% α-cyclodextrin.

This invention also relates to a method of reducing triglyceride levelsin a subject comprising administering to a subject in need thereof anamount of α-cyclodextrin sufficient to reduce triglyceride levels. Theamount of α-cyclodextrin administered to the subject is such that theratio of α-cyclodextrin to fat ingested per meal, or daily, by thesubject is about 1:20 to about 1:3 w/w, preferably the ratio is about1:13 to about 1:5 w/w and more preferably the ratio is about 1:9 w/w.The α-cyclodextrin may be administered in a variety of forms, e.g., atablet, capsule, pill, elixir, wafer, beverage, or in food products,e.g., bread products, e.g., buns, rolls, biscuits, and breakfast cereal,e.g., oatmeal, cream of wheat, raisin bran, corn flakes, or other readyto eat cereals, and, particularly the consumable food products of thisinvention. The tablet, pill, capsule, elixir, wafer, beverage, or foodproducts may contain α-cyclodextrin in combination with othercyclodextrins, e.g. β and/or γ cyclodextrins or with n-dextrin, butpreferably the cyclodextrin in the tablet, pill, capsule, elixir, wafer,beverage or the food products is predominantly α-cyclodextrin, e.g., thecyclodextrin is at least about 90-98% α-cyclodextrin.

This invention further relates to a method for reducing leptin levels ina subject comprising administering α-cyclodextrin to a subject in needthereof in an amount and for a time sufficient to reduce leptin levelsin the subject. The α-cyclodextrin may be administered in a variety offorms, e.g., a tablet, capsule, pill, elixir, wafer, beverage or in foodproducts, e.g., bread products, buns, rolls, biscuits and breakfastcereal, e.g., oatmeal, cream of wheat, raisin bran, corn flakes, orother ready to eat cereals, and particularly the consumable foodproducts of this invention. The tablet, pill, capsule, elixir, wafer,beverage or food products may contain α-cyclodextrin in combination withother cyclodextrins, e.g. p and/or y cyclodextrins or with n-dextrin,but preferably the cyclodextrin in the tablet, pill, capsule, elixir,wafer, beverage or the food products is predominantly α-cyclodextrin,e.g., the cyclodextrin is at least about 90-98% α-cyclodextrin.

This invention also relates to a method for suppressing appetite byadministering α-cyclodextrin to a subject in need thereof in an amountand for a time sufficient to suppress the subject's appetite. The amountof α-cyclodextrin administered to the subject is such that the ratio ofα-cyclodextrin to fat ingested per meal, or daily, by the subject isabout 1:20 to about 1:3 w/w, preferably the ratio is about 1:13 to about1:5 w/w and more preferably the ratio is about 1:9 w/w. Theα-cyclodextrin may be administered in a variety of forms, e.g., atablet, capsule, pill, elixir, wafer, beverage or in food products,e.g., bread products, buns, rolls, biscuits, and breakfast cereal, e.g.,oatmeal, cream of wheat, raisin bran, corn flakes, or other ready to eatcereals, and particularly the consumable food products of thisinvention. The tablet, pill, capsule, elixir, wafer, beverage or foodproducts may contain α-cyclodextrin in combination with othercyclodextrins, e.g. β and/or γ cyclodextrins or with n-dextrin,preferably the cyclodextrin in the tablet, pill, capsule, elixir, wafer,beverage or the food products is predominantly α-cyclodextrin, e.g., thecyclodextrin is at least about 90-98% α-cyclodextrin.

This invention further relates to a method for reducing insulin levelsand insulin resistance in a subject comprising administeringα-cyclodextrin to a subject in need thereof in an amount and for a timesufficient to reduce insulin levels and insulin resistance in thesubject. Preferably the amount of α-cyclodextrin administered to thesubject is such that the ratio of α-cyclodextrin to fat ingested permeal or daily by the subject is in a ratio of about 1:20 to about 1:3w/w, preferably the ratio is about 1:13 to about 1:5 w/w and morepreferably the ratio is about 1:9 w/w. The α-cyclodextrin may beadministered in a variety of forms, e.g., a tablet, capsule, pill,elixir, wafer, .beverage or in food products, e.g., bread products,buns, rolls, biscuits, and breakfast cereal, e.g., oatmeal, cream ofwheat, raisin bran, corn flakes, or other ready to eat cereal, andparticularly the consumable food products of this invention. Preferablythe cyclodextrin in the tablet, pill, capsule, elixir, wafer, beverageor food products is predominantly α-cyclodextrin, e.g., the cyclodextrinis at least about 90-98% α-cyclodextrin.

This invention also relates to a method for reducing diarrhea in asubject in need thereof comprising administering to a subject in needthereof α-cyclodextrin in an amount and for a time sufficient to reducediarrhea in the subject. Preferably the amount of α-cyclodextrinadministered to the subject is such that the ratio of α-cyclodextrin tofat ingested per meal or daily by the subject is in a ratio of about1:20 to about 1:3 w/w, preferably the ratio is about 1:13 to about 1:5w/w and more preferably the ratio is about 1:9 w/w. The α-cyclodextrinmay be administered in a variety of forms, e.g., a tablet, capsule,pill, elixir, wafer, beverage or in food products, e.g., bread products,buns, rolls, biscuits, and breakfast cereal, e.g., oatmeal, cream ofwheat, raisin bran, corn flakes, or other ready to eat cereals, andparticularly the consumable food products of this invention. Preferablythe cyclodextrin in the tablet, pill, capsule, elixir, wafer, beverageor the food products is predominantly α-cyclodextrin, e.g., thecyclodextrin is at least about 90-98% α-cyclodextrin.

This invention also relates to methods for enhancing organolepticproperties of a fat containing food product without reducing thepercentage of fat in the food product or the caloric content due to thefat, as assayed by bomb calorimetry. The method comprises addingα-cyclodextrin to the fat containing food product such that it ispresent during processing and in the final ingested food product. Theamount of α-cyclodextrin that is added to the food product may be basedon the amount of fat in the finished consumable product.

BRIEF DESCRIPTION OF THE FIGURES

The patent or application file contains at least one drawing executed incolor. Copies of this patent or patent application publication withcolor drawing(s) will be provided by the Office upon request and paymentof the necessary fee.

FIG. 1 depicts the cumulative total mass of food consumed by the fourgroups of rats and demonstrates that there was no significant differencein the mass of food consumed by the different groups.

FIG. 2 depicts the cumulative caloric intake of the four groups of ratsand indicates that there was no significant difference in the caloriesof food that the two pairs of rats (low fat and high fat) consumed.

FIG. 3 illustrates the change in body weight of the four groups of adultrats during the entire study period.

FIG. 4 depicts the fecal fat content of four groups of rats. Groupssharing a common superscript are not significantly different.

FIG. 5 depicts the blood plasma parameters of four groups of rats atsacrifice. The plasma glucose, cholesterol and triglycerideconcentrations were measured on all of the animals.

FIG. 6 compares the plasma leptin values obtained from the four groupsof rats.

FIG. 7 depicts the serum triglyceride levels of volunteers fed a highfat breakfast following an overnight fast.

FIG. 8 depicts the change in body weight of a human volunteer over aperiod of approximately 6 months.

FIG. 9A-9C depicts the results of an in vitro study of vegetable oil (4g), water (6 g) (with added food coloring for contrast) and varyingamounts of (A) α-cyclodextrin (100-2,000 mg, right to left), (B)β-cyclodextrin or (C) γ-cyclodextrin. A band of “wax-like” materiallayered between the oil and aqueous phases is apparent in the tubes. Thesize of this band increases with increasing amounts of α-cyclodextrin toa maximum in the tube labeled 10% (400 mg α-cyclodextrin/4 g oil). Notethe increasing size (right to left) of a white layer of un-reactedα-cyclodextrin in the bottom of the tubes. This material is displacedfrom solution by either the oil or the α-cyclodextrin-oil complex. Thesetubes were centrifuged in order to improve the definition of the layers.The “wax-like” complex is of such a consistency that all of the tubesexcept for the furthest two to the right can be inverted without leakageof the aqueous phase around the complex.

DESCRIPTION OF THE INVENTION

This invention relates to a fat containing consumable food productcontaining α-cyclodextrin and to methods for its use. The consumablefood products are suitable for consumption by mammals, e.g., a mouse,rat, a cat, a dog, a cow, a horse, a monkey, an ape or a human, and thusinclude e.g., a pet food product for a e.g. cat, dog or horse or a humanconsumable food product. The consumable food products of this inventioncomprise α-cyclodextrin and fat, preferably the ratio of the amount ofα-cyclodextrin to fat is about 1:20-1:3 w/w, more preferably the ratioof α-cyclodextrin to fat of about 1:13-1:5 w/w, and most preferably theratio of α-cyclodextrin to fat of about 1:9 w/w. Preferably the totalcyclodextrin in the consumable food products is less than about 9% w/w,more preferably the total cyclodextrin in the consumable food productsis less than about 6% w/w and most preferably the total cyclodextrin inthe food products is less than about 3%. Preferably complexes ofcyclodextrin and fat are distributed evenly throughout the food product.Preferably the consumable food products of this invention are high fatcontaining food products comprise by caloric content about 7% to about80% fat, preferably about 20% to about 70% fat, more preferably about40% to about 70% fat, or by weight about 5% w/w fat to about 50% w/w fatpreferably about 5-30% w/w fat and more preferably about 7% w/w fat toabout 25% fat. Methods for determining or calculating the amount of fatin a food product are well known in the art. See for example thesoftware program “Food Processor” by ESHA Research, Salem, Oreg.,incorporated herein by reference. Preferably the food products of thisinvention are made with less than 2% linolenic acid, more preferablyless than 0.2% linolenic acid. More preferably the food products of thisinvention are made without detectable levels of linolenic acid.Linolenic acid has been shown to promote weight loss but at the levelsnecessary to promote weight loss, about 2%, the shelf life of productscontaining the linolenic acid are reduced due to its tendency to becomerancid. In addition, high purity linolenic acid is very expensive. Thuslinolenic acid is preferably not added to the food products of thisinvention before, during or after their preparation.

Various forms of cyclodextrins are commercially available. For example,Wacker-Chemie GmbH produces a variety of natural and modifiedcyclodextrins. Cyclodextrins are often sold as mixtures of α-, β- andγ-cyclodextrins and can be produced by a variety of methods. Generallycyclodextrins are produced by treating a starch, e.g. potato or corn,with a cyclodextrin transferase, which is produced by a variety oforganisms, e.g., Bacillus macerans. The cyclodextrins may be isolatedfrom the treated starch using a variety of methods that combineconcentration, fractionation, filtration, spray drying, granulation etc.For a more complete discussion of methods for the production andisolation of cyclodextrins see e.g. Schmid “Preparation and industrialproduction of cyclodextrins”, Comprehensive Supramolecular Chemistry(1996), 3: 41-56. Eds Szejtli, Jozsef; Osa, Tetsuo. Elsevier, Oxford, UKincorporated herein by reference.

The fat containing consumable food products of this invention may be afarinaceous food product, e.g., snack bars, breakfast cereals, pancakes,waffles, muffins, fruit filled pastries, tortillas, corn chips, tortillachips, snack crackers, breads, cakes, cookies, or pies, or anon-farinaceous food product, e.g. a prepared vegetable product(vegetables as described herein include vegetables, fruits and nuts),particularly those made with a fat ingredient, e.g. french fries,tempura, veggie burgers, refried beans, hummus, tahini, margarine andnut butters, (e.g., peanut, cashew, almond, hazelnut), marzipan, potatochips; a dairy food product e.g., milk, cream, pudding, butter, icecream, and cheese and processed cheese products; yogurt and yogurtproducts, egg products and meat products, e.g., prepared beef, lamb,pork, poultry or seafood products, e.g., frankfurters, deli slices,sausages, fish sticks, chicken fingers, and ground meats, e.g.,meatloaf, meatballs and hamburgers. Preferably the dairy product is onewherein α-cyclodextrin/fat complexes are distributed throughout theproduct, preferably a solid or semi-solid dairy product e.g., pudding,butter, ice cream, and cheese and processed cheese products and yogurtand preferably the organoleptic properties of the product are notadversely affected. The food products of this invention may also includeamong others, e.g., a pre-packaged farinaceous food product, e.g., apre-packaged prepared pasta dish such as, e.g., lasagna, manicotti,spaghetti with sauce, ravioli, tortellini, or macaroni and cheese, or apackaged dairy product, a packaged prepared vegetable product, or apre-packaged prepared meat product, wherein the food product comprisesα-cyclodextrin and fat in ratios as set forth herein. Preferably, aserving of the pre-packaged product provides about 160 mg to 11 gα-cyclodextrin/serving, preferably about 1 g to about 7 g/serving andmore preferably about 2-4 g per serving, and most preferably at about2-3 g/serving. A pre-packaged food product may be enclosed in plastic,paper, cardboard or metal, e.g., tin or flexifoil. The pre-packaged foodproduct may be packaged in bulk, multiserving packages or packaged assingle servings.

This invention also relates to confectionery products e.g., hard candiessuch as lollipops and breath mints or after dinner mints, andcondiments, e.g., gravies, sauces, salad dressings, mayonnaise etc.,comprising α-cyclodextrin. Preferably, the confectionery product is afat containing product such as, e.g., chocolates.

The α-cyclodextrin may be added to a consumable food product that iscooked, e.g., baked, roasted or fried, or to an uncooked consumable foodproduct, e.g., milk, cream, whipped cream, non-dairy whipped toppings orfillings, yogurt or a beverage, e.g. a milkshake, eggnog, or a smoothie(fruit and yogurt drink). The α-cyclodextrin may be added to the foodproduct at any stage of its preparation, e.g., the α-cyclodextrin may bemixed with the ingredients so that it is distributed throughout the foodproduct and the product may then be cooked. However, in some instancesthe α-cyclodextrin may be applied to the surface of the food product,e.g., as a glaze or coating, to achieve the desired levels ofα-cyclodextrin to fat.

This invention also relates to a method for promoting weight loss orreducing body weight gain in a subject comprising administering to asubject in need thereof an amount of α-cyclodextrin sufficient to reducebody weight gain or promote weight loss. A preferred method comprisingingesting sufficient amounts of α-cyclodextrin to complex a desiredamount of fat in a fat containing meal, or desired amount of fat perday, to promote weight loss, reduce weight gain or to maintain weight.Preferably the weight loss for a human that is about 1-1.5 lbs/week. Anaspect of this invention is a method comprising ingesting sufficientamount of α-cyclodextrin to complex the fat in excess of a desiredamount of fat per meal or day that a subject wishes to absorb. Themethod comprises determining the amount of fat that a subject desires toabsorb per meal or per day, determining the amount of ingested fat thatin excess of the amount that the subject desires to absorb, and theningesting sufficient amounts of α-cyclodextrin to complex the excess fatsuch that only the desired amount of fat is absorbed. For example, basedon the disclosure herein that about 1 g of α-cyclodextrin can complexabout 9 g of fat, the amount sufficient to promote a weight loss of1-1.5 lbs/week in a subject consuming a daily diet of 2500 g/day, suchdiet comprising about 100 g fat/day, the preferred amount of ingestedα-cyclodextrin is about 2 g/meal three meals a day. Preferably the totalα-cyclodextrin ingested daily is about 500 mg to about 33 g per day,more preferably about 5 g to about 20 g per day, most preferably about6-11 g/day. Preferably the α-cyclodextrin is administered with a mealsuch that the ratio of α-cyclodextrin to the ingested fat that onewishes to prevent from being absorbed by the body is about 1:20 w/w toabout 1:3 w/w, preferably the ratio is about 1:13 w/w to about 1:5 w/w,more preferably the ratio is about 1:9 w/w. A subject in need thereof isone who is in need of or who wishes to lose weight or inhibit weightgain, e.g., one who is prone to weight gain or one who is alreadyoverweight or obese. The subject may also be one who consumes a dailydiet comprising about 30% or more fat by calorie. The α-cyclodextrin maybe administered to the subject in the form of a powder, a tablet, acapsule, a drink or another delivery medium suitable for consumption,preferably one that does not comprise linolenic acid. The α-cyclodextrinmay be administered prior to, concurrently with or subsequent to,ingestion of a fat containing meal. Preferably the α-cyclodextrin isadministered just prior to or concurrently with the ingestion of a fatcontaining meal. More preferably the α-cyclodextrin is administered to ahuman subject while consuming a fat containing meal. The α-cyclodextrinmay be administered in the form of a food product, e.g., bread products,e.g., buns, rolls, or biscuits, or a breakfast cereal, e.g., oatmeal,cream of wheat, raisin bran, corn flakes, or other ready to eat cereal,or preferably in the form of the food products of this invention. Thesubject may be a mammal, e.g., mouse, rat, cat, dog, cow, horse, monkey,ape or human but preferably human and it is within the skill of the artto adjust the total amounts of α-cyclodextrin administered to the mammalto complex sufficient fat to achieve the desired amount of weight loss.For example, 2 g of α-cyclodextrin per meal reduces the bioavailabilityof about 18 g of fat per meal or about 54 g of fat per day. This equatesto 1-1.5 lbs of body weight per week. This amount of fat representsapproximately one-half of the normal daily fat consumption for averageNorth Americans.

This invention also relates to methods for reducing the bioavailabilityof fat in a fat containing food product comprising combining an amountof an α-cyclodextrin with a food product such that the food productcomprises a ratio of α-cyclodextrin to fat of about 1:20 to about1:3w/w, preferably about 1:13 to about 1:5 w/w most preferably about 1:9w/w. Preferably the total cyclodextrin in the food products of thisinvention is less than about 9% w/w, more preferably less than about 6%w/w and most preferably less than about 3% w/w. This method may beapplied to a variety of fat containing food products, e.g., afarinaceous food product, a prepared vegetable product, a dairy product,a prepared meat or seafood product, gravies, sauces and salad dressings.For example, the farinaceous food product may be a e.g. snack bar,breakfast cereal, pancakes, waffles, muffins, tortillas, corn chips,tortilla chips, snack crackers, breads, cakes, cookies, doughnuts,zeppolies and pies. A dairy product of this invention may be e.g., milk,cream, evaporated or condensed milk, pudding, butter, ice cream,milkshakes, yogurt and drinks prepared with yogurt, e.g., a fruit andyogurt “smoothie”, and cheese or processed cheese products or eggproducts, e.g. an omelet or egg noodles. The vegetable product may beone which is made with fat as one of the ingredients, cream basedvegetable soup, soups with meat based stocks, or a vegetable burger, orthe vegetable product may be one which is fried in a fat containingmaterial, e.g., french fries, potato chips or falafel, wherein theamount of α-cyclodextrin in the product is based on the estimate of theamount of fat containing material that will be absorbed in the finalproduct. The meat product may be a prepared beef, lamb, pork, poultry orseafood product, e.g., frankfurters, deli slices, sausages, fish sticks,chicken fingers and ground meats to be made into, e.g., hamburgers ormeatloaf. The method is also applicable to battered or coated products,e.g., french fries, fish sticks, chicken fingers or tempura, that arefried and to batters that are used to coat products that are fried in afat containing material. The amount of cyclodextrin in the batter of abatter coated product is based on the estimate of the amount of fatcontaining material that will be absorbed by the batter coated product.The method is also applicable to candies and condiments, e.g.,chocolates, sauces, mayonnaise and salad dressings.

The α-cyclodextrin may be added to the consumable food product at anystage in its production and may be added under conditions that favorformation of complexes of α-cyclodextrin and fat such that the complexesare distributed throughout the consumable food product. Alternatively,the α-cyclodextrin may be combined with a fat containing food product asit is consumed by determining the approximate amount of fat in the foodproduct and then ingesting α-cyclodextrin in amount sufficient to obtaina ratio of ingested α-cyclodextrin to ingested fat of 1:20 to about 1:3,preferably 1:13 to about 1:5 and more preferably about 1:9 w/w.Preferably, the consumable fat containing food product comprises bycaloric content 7-80% fat, more preferably 20-70% fat and mostpreferably 40-70% fat or by weight 5-50% fat, preferably 7-25% fat.

This invention also relates to methods for reducing a pathologiccondition often associated with obesity and excess weight, e.g., highcholesterol (HDL ratio, high triglyceride levels, high leptin levels,high insulin levels, and insulin resistance, by administeringα-cyclodextrin to a subject in need thereof in sufficient amounts andfor sufficient time to reduce the pathologic condition associated withobesity and excess weight.

Serum cholesterol is found in combination with proteins in the blood ofparticular interest are high density (HDL) and low density lipoproteins(LDL). This invention also relates to a method for increasing the levelof high density lipoprotein cholesterol (HDL) in a subject comprisingadministering α-cyclodextrin to a subject in need thereof in an amountsufficient, and for a time sufficient, to increase HDL levels.Preferably the amount of α-cyclodextrin administered to the subject isabout 500 mg to about 33 grams per day, preferably about 3-21 g per dayand more preferably about 6-11 g per day. The α-cyclodextrin may beadministered prior to, concurrently with or subsequent to ingestion of afat containing meal. The subject may be one who consumes about 100 gfat/day. Preferably the α-cyclodextrin is administered to the subjectwith a fat containing meal. A sufficient amount of α-cyclodextrin isabout 165 mg-11 g/meal, preferably about 1-7 g/meal or more preferablyabout 2-3.3 g meal. The α-cyclodextrin may be administered in anysuitable form, e.g., a tablet, pill, capsules liquid or other deliverymedium suitable for human consumption, or in the form of food products,e.g., bread products, buns, rolls, biscuits, and breakfast cereal, e.g.,oatmeal, cream of wheat, raisin bran, corn flakes, or other ready to eatcereal, and particularly the food products of this invention. Preferablya serving size of the food product for use in this method contains about165 mg-11 g/meal, preferably about 1-7 g/meal or more preferably about2-4 g α-cyclodextrin. Preferably, the α-cyclodextrin is administered tothe subject in an amount such that the ratio of α-cyclodextrin to fat ofabout 1:20 to about 1:3 w/w, preferably about 1:13 to about 1:5 w/w,most preferably about 1:9 w/w per meal, or daily.

It is possible that the total levels of cholesterol in the blood willremain constant even though the levels of HDL are elevated if there is areduction in levels of LDL. Thus another aspect of this invention ismethod for increasing HDL levels and reducing LDL levels, reducing thecholesterol/HDL ratio, and or reducing cholesterol levels in a subjectin need thereof by administering α-cyclodextrin in an amount and for atime sufficient to increase the HDL levels and/or reduce the LDL levels,decrease the total cholesterol/HDL ratio and/or reduce cholesterol. Thereduction in LDL and increase in HDL reduces the total ratio ofcholesterol to HDL. Preferably the total cholesterol levels are notsubstantially reduced or increased.

The α-cyclodextrin may be administered to the subject in the form of apowder, tablet, a capsule, a drink or another delivery medium suitablefor consumption, preferably one that does not comprise linolenic acid. Asufficient amount of α-cyclodextrin is about 165 mg-11 g/meal,preferably about 1-7 g/meal or more preferably about 2-3.3 g/meal.Preferably the total α-cyclodextrin ingested daily is about 500 mg toabout 33 g per day, more preferably about 5 g to about 20 g per day,most preferably about 6-11 g/day. Preferably the α-cyclodextrin isadministered with a meal such that the ratio of α-cyclodextrin to fat isabout 1:20 w/w to about 1:3 w/w, preferably the ratio is about 1:13 w/wto about 1:5 w/w, more preferably the ratio is about 1:9 w/w per meal.

A subject in need of increasing the level of HDL and/or reducing LDLLevels, reducing the cholesterol/HDL ratio or reducing cholesterollevels is one who has, or has a predisposition for, a high ratio oftotal cholesterol to HDL levels. Methods for determining bloodcholesterol, HDL and LDL levels are well known in the art and need notbe elaborated on herein. However, for a discussion of cholesterol levelsand methods for determining cholesterol, HDL and LDL levels (see e.g.,Expert Program on detection, evaluation, and treatment of high bloodcholesterol in adults. Executive Summary of the Third Report of theNational Cholesterol Education Panel on Detection, Evaluation, andTreatment of High Blood Cholesterol in Adults (Adult Treatment PanelIII), JAMA 285(19); 2486-97:2001, and; Handbook of Lippoprotein Testing,Rifai N, Warnick G R and Dominiczak M H, eds. Chapters 9, 11 and 12.AACC Press, Washington D.C., 2000 both incorporated herein byreference.)

This invention also relates to a method of reducing triglycerides in asubject comprising administering to a subject in need thereof an amountof α-cyclodextrin sufficient to reduce triglyceride levels. A subject inneed thereof is one who has high triglyceride levels, has apredisposition for high triglyceride levels or has a family history ofhigh triglyceride levels. High triglyceride levels are implicated in avariety of pathological conditions. Thus, this invention also relates totreating a pathological condition, e.g., cardiovascular disease, acutepancreatitis, insulin resistance and uncontrolled diabetes and variousdislipidernias associated with high triglyceride levels by administeringα-cyclodextrin to a subject in need thereof in an amount sufficient toreduce the levels of triglyerides in the subject. Those of skill in theart are well versed in methods for determining the triglyceride levelsin a subject. For a review of methods for determining blood triglyceridelevels see e.g., Handbook of Lipoprotein Testing, Rifai N, Warrick GRand Dorniniczak MB, eds. Chapter 10. AACC Press, Washington, D.C. 2000incorporated herein by reference. The α-cyclodextrin may be administeredprior to, concurrently with or subsequent to ingestion of the fatcontaining meal. More preferably the α-cyclodextrin is administered tothe subject with a fat containing meal. A sufficient amount ofα-cyclodextrin is about 165 mg-11 g/meal, preferably about 1-7 g/meal ormore preferably about 2-4 g meal. Preferably the total α-cyclodextriningested daily is about 500 mg to about 33 g per day, more preferablyabout 5 g to about 20 g per day most preferably about 6-11 g/day.Preferably the α-cyclodextrin: fat ratio ingested per meal or daily isabout 1:20 to about 1:3 w/w, preferably the ratio is about 1:13 to about1:5 w/w and more preferably the ratio is about 1:9 w/w. Theα-cyclodextrin may be administered to the subject in the form of apowder, tablet, a capsule, a drink or another delivery medium suitablefor consumption, preferably one that does not comprise linolenic acid.The cc-cyclodextrin may be administered to the subject in the form of afood product, particularly a food product of this invention.

This invention further relates to a method for reducing leptin levels ina subject comprising administering α-cyclodextrin to a subject in needthereof in an amount sufficient to reduce leptin levels in the subject.The α-cyclodextrin may be administered prior to, concurrently with orsubsequent to ingestion of the fat containing meal. Preferably theα-cyclodextrin is administered just prior to or concurrently with theingestion of the fat containing meal. More preferably the α-cyclodextrinis administered to the subject with a fat containing meal. The amount ofα-cyclodextrin ingested per meal is preferably about 165 mg-11 g/meal,more preferably 1-7 g/meal and most preferably 2-3.3 g/meal. Preferablythe total α-cyclodextrin ingested daily is about 500 mg to about 33 gper day, more preferably about 5 g to about 20 g per day most preferablyabout 6-11 g/day. Preferably the amount of α-cyclodextrin administereddaily to the subject and fat ingested daily by the subject is in a ratioof about 1:20 to about 1:3 w/w, preferably the ratio is about 1:13 toabout 1:5 w/w and more preferably the ratio is about 1:9 w/w. A subjectin need of reducing leptin is one who has high leptin levels, has apredisposition for leptin resistance. Leptin levels can be determinedusing any method known in the art for determining leptin levels. For areview of various assays for determining leptin resistance see e.g.,Maffei et al., Nature Med 1:1155-1161 (1995) incorporated herein byreference. The α-cyclodextrin may be administered to the subject in theform of a powder, tablet, capsule, drink, confection or other deliverymedium suitable for human consumption, preferably one that comprisesless that 2% linolenic acid, more preferably one that comprises lessthan 0.2% linolenic acid and most preferably one that does not compriselinolenic acid. The α-cyclodextrin may be administered to the subject inthe form of a food product, preferably a food product of this invention.

This invention further relates to a method for reducing blood insulinlevels and insulin resistance in a subject comprising administeringα-cyclodextrin to a subject in need thereof in an amount sufficient toreduce blood insulin levels in the subject. Insulin resistance istypically the cause of Type II diabetes. Insulin resistance can beestimated by triglyceride/HDL-cholesterol ratios and glucose/insulinratios. A subject in need thereof is one who displays high insulinlevels, has Type II diabetes or who has a predisposition for developingType II diabetes or who has a family history of high insulin levels orType II diabetes. Any method used routinely for determining insulinlevels can be used herein to assay and monitor insulin levels andresistance. See for example Berson et al. (Eds) Methods in.Investigative and Diagnostic Endocrinology, ch 3, Part III, Vol. 28.American Elsevier Publishing Co., New York, 1973, incorporated herein byreference, for a description of assays for determining insulin levels.The α-cyclodextrin may be administered prior to, concurrently with orsubsequent to ingestion of the fat containing meal. Preferably theα-cyclodextrin is administered just prior to or concurrently with theingestion of the fat containing meal. More preferably the α-cyclodextrinis administered to the subject with a fat containing meal. The amount ofα-cyclodextrin ingested per meal is preferably about 165 mg-11 g/meal,more preferably about 1-7 g/meal and most preferably about 2-3.3 g/meal.The total α-cyclodextrin ingested daily is about 500 mg to about 33 gper day, preferably about 5 g to about 20 g per day and more preferablyabout 6-11 g/day. Preferably the amount of α-cyclodextrin administereddaily to the subject is based on the fat ingested daily by the subjectand is in a ratio of about 1:20-1:3 w/w, preferably the ratio is about1:13-1:5 w/w and more preferably the ratio is about 1:9 w/w. Theα-cyclodextrin may be administered to the subject in the form of apowder, tablet, a gel, capsule, a liquid or another delivery mediumsuitable for human consumption, preferably one that does not compriselinolenic acid. The α-cyclodextrin may be administered to the subject inthe form of a food product, preferably a food product of this invention.

This invention also relates to a method for reducing diarrhea in asubject in need thereof comprising administering to a subject in needthereof α-cyclodextrin in an amount and for a time sufficient to reducediarrhea in the subject. The subject may be a mammal, e.g., mouse, rat,cat, dog, cow, horse, monkey, ape or human. Such a subject may be onewho is prone to diarrhea, or is currently suffering from diarrhea, e.g.,the subject may be a cholecystectomy patient prone to or havingdiarrhea, a patient suffering from fat aggravated diarrhea, or a patienthaving acute or subacute diverticulitis, the acute phases of certaininflammatory conditions of the bowel, e.g., ulcerative colitis orCrohn's disease and after some types of intestinal surgery, e.g., acolostomy or ileostomy. The α-cyclodextrin may be administered in theform of a food product, preferably a food product of this invention forexample a farinaceous or non-farinaceous food product of this invention.The α-cyclodextrin may also be administered to the subject in the formof a powder, tablet, a capsule, a gel, a liquid or another deliverymedium suitable for consumption. The α-cyclodextrin may be administeredwith a meal at about e.g. 165 mg-11 g/meal, preferably about 1-7 g/mealand more preferably about 2-3.3 g/meal. Preferably the totalα-cyclodextrin ingested daily is about 500 mg to about 33 g per day,more preferably about 5 g to about 20 g per day, most preferably 6-11g/day. The ratio of ingested α-cyclodextrin to ingested fat per meal, ordaily, preferably per meal, is about 1:20-1:3 w/w, preferably the ratiois about 1:13-1:5 w/w, more preferably the ratio is about 1:9 w/w. Theα-cyclodextrin may be administered prior to, concurrently with orsubsequent to ingestion of the fat containing meal. Preferably theα-cyclodextrin is administered just prior to or concurrently with theingestion of the fat containing meal.

The addition of α-cyclodextrin to a pet food product maintains orpromotes good feces quality of a pet and/or improves feces quality of apet Good quality pet feces is a very desirable trait as perceived by thepet owner in that it is not only generally more aesthetically pleasingbut is also an indicator of good pet health. As such, this invention isalso related to a pet food product which comprises α-cyclodextrin in anamount sufficient to maintain or promote good feces quality of a petand/or improve the feces quality of a pet. Feces having good quality arefirm and well formed maintaining their shape. A feces with a moisturecontent such that the shape is not maintained (loose stools or diarrhea)or a moisture content such that the feces are hard and dry, are not goodquality feces. The pet food is preferably a packaged pet food. Thepackaging may be plastic, paper, cardboard or metal, e.g. tin orflexifoil. The pet food may be a moist pet food, such as those packagedin cans or flexifoil or a dry pet food such as those packaged in paperor cardboard, e.g., kibble or biscuits. Preferably the pet food is afood developed for a cat, dog, cow or horse. This invention also relatesto a method for maintaining or promoting good feces quality of a petand/or improving feces quality of a pet by administering α-cyclodextrinto a pet, preferably a pet in need thereof, in an amount and for a timesufficient to maintain or promote good feces quality of the pet and/orto improve feces quality of a pet. The α-cyclodextrin may beadministered with a meal at about e.g. 165 mg-11 g/meal, preferablyabout 1-7 g/meal and more preferably about 2-3.3 g/meal. Preferably thetotal α-cyclodextrin ingested daily is about 500 mg to about 33 g perday, more preferably about 5 g to about 20 g per day, most preferably6-11 g/day. The ratio of ingested α-cyclodextrin to ingested fat permeal, or daily, preferably per meal, is about 1:20-1:3 w/w, preferablythe ratio is about 1:13-1:5 w/w, more preferably the ratio is about 1:9w/w. The α-cyclodextrin may be administered prior to, concurrently withor subsequent to ingestion of the fat containing meal. Preferably theα-cyclodextrin is administered just prior to or concurrently with theingestion of the fat containing meal. The α-cyclodextrin may beadministered to the pet in the form of a pill, wafer, tablet capsule etcor in the form of a pet food product, particularly a pet food product ofthis invention, including moist pet foods such as that packaged in a canor flexifoil or a dry pet food such as those packaged in a paper orcardboard container e.g. a kibble or biscuit. A pet in need thereof isone having poorly formed feces or having a predisposition to have poorlyformed feces, e.g. a pet with diarrhea or having a predisposition todiarrhea.

In the methods of this invention, the α-cyclodextrin may be administeredin the form of a single dosage unit consisting essentially ofα-cyclodextrin. The single dosage unit may be in the form of a powder,tablet, capsule, gel, pellet, liquid, etc., the α-cyclodextrin may beincorporated into a powder, tablet, capsule, gel, pellet, liquid, etc byany means that is routinely used in the art. The α-cyclodextrin may beincorporated into the powder, tablet, gel, capsule, pellet, liquid, etc.with other commonly used additives, e.g. colorants, antioxidants,fillers, starches, sugars, anti-bacterial or anti-fungal agents,preservatives, stabilizers or emulsifiers. The α-cyclodextrin may becombined with any pharmaceutical carrier acceptable for oraladministration, e.g. it may be enclosed in a hard or soft shell gelatincapsule, compressed into tablets, or incorporated directly into theindividual's diet. Specifically, α-cyclodextrin may be incorporated withexcipients and used in the form of digestible tablets, capsules,elixirs, suspensions, syrups, wafers, and the like. The α-cyclodextrinmay be mixed with other food forms and pharmaceutically acceptableflavor enhancers. Suitable pharmaceutical carriers and formulations aredescribed, for example, in Remington's Pharmaceutical Sciences (19thed.) (Genarro, ed. (1995) Mack Publishing Co., Easton, Pa.),incorporated herein by reference. Preferably the formulation is suchthat the α-cyclodextrin is released in the stomach to mix with theingested food so that complexes of α-cyclodextrin and fat are formedsuch that the α-cyclodextrin: fat complexes are already formed when thechyme is pushed into the jejunum and is mixed with bicarbonate andlipase.

Because only a relatively small amount of total cyclodextrin (e.g. lessthan about 9% w/w preferably less than about 6% w/w, more preferableless than about 3% w/w) is added to food products to achieve the desiredα-cyclodextrin to fat ratio, the α-cyclodextrin may be added to a foodcomposition rather than using α-cyclodextrin as a filler to replace anequal amount of the dry ingredients in the food product. Thus thecaloric content of the food products of this invention as determined bybomb calorimetry is not substantially altered by the addition of total.cyclodextrin. Even if dry ingredients are removed from the food productto compensate for the relatively small amount of cyclodextrin added tothe food product (less than about 9% preferably less than about 6% w/w,more preferably less than about 3% w/w) the caloric content of the foodwould not be substantially reduced.

This invention also relates to methods for enhancing organolepticproperties of a fat containing consumable food product without reducingthe caloric content (as assayed by bomb calorimetry) or substantiallyreducing the percentage of fat in the food product. The method comprisesadding α-cyclodextrin to the fat containing food product during thepreparation of the product. The amount of α-cyclodextrin added to thefoods is based on the amount of fat in the finished product. The foodproducts of this invention typically have a ratio of α-cyclodextrin tofat of about 1:20-1:3 w/w, preferably about 1:13-1:5 w/w, and morepreferably about 1:9 w/w. The total amount of cyclodextrins added to theproduct is typically less than 9% w/w, preferably less than 6% w/w andmore preferably less than 3% w/w. Products made with as low as 0.7% w/wα-cyclodextrin have enhanced organoleptic properties, e.g. a sweetertaste and a smoother texture. The consumable fat containing food productmay comprise by calorie content 7-80% fat, preferably 20-70% or morepreferably 40-70% fat or by weight 5-50% w/w fat or preferably 7-25% w/wfat. This method may be applied to a variety of fat containing foodproducts, e.g., a farinaceous food product, a prepared vegetableproduct, a dairy product, a prepared meat poultry or seafood product,soups and condiments e.g., gravies, sauces, mayonnaise, salad dressingetc. For example, the farinaceous food product may be e.g., a snack bar,breakfast cereal, pancake, waffle, muffin, tortilla, corn chips,tortilla chips, snack cracker, bread, cake, cookie, doughnut zeppoli andpie or other fruit or nut filled baker product. A dairy product of thisinvention may be e.g., milk, cream, evaporated or condensed milk,pudding, butter, ice cream milkshakes, and cream based sauces or soups,yogurt and drinks prepared with yogurt, e.g., a fruit and yogurt“smoothie”, and cheese or processed cheese products, or egg products,e.g., an omelet or egg noodles. The vegetable product may be one whichis made with fat as one of the ingredients, e.g., hummus, tahini,margarine and nut butters, or may be one which is fried in a fatcontaining material, e.g., french fries, vegetable tempura, or falafel,wherein the amount of a α-cyclodextrin in the fried product is based onthe amount of fat containing material that is estimated to be containedin the fried food product after frying. The meat product may be aprepared beef, lamb, pork, poultry or seafood product, e.g.,frankfurters, deli slices, sausages, fish sticks, chicken fingers andground meats to be made into, e.g., hamburgers, meatballs or meatloaf.The method is also applicable to batters that are used to coat products,e.g., french fries or tempura, for frying in a fat containing material,e.g., lard or oil. In addition the method is applicable to soups, andcondiments, e.g., gravies, sauces and salad dressing, wherein theα-cyclodextrin to fat ratio described supra may enhance the textureand/or flavor of the product. The products of this invention often tastecomparable to a like product made without α-cyclodextrin and/or theyhave a smoother texture and a sweeter taste. In addition, the inclusionof α-cyclodextrin in evaporated or condensed milk produces a whiterproduct as compared to a like product without the α-cyclodextrin.

This invention also relates to a method for reducing the amount of timerequired to prepare whipped cream comprising adding α-cyclodextrin tocream prior to or during whipping. The α-cyclodextrin is added in anamount sufficient to reduce the amount of time required to form whippedcream. Preferably the amount of α-cyclodextrin is sufficient to attain aratio of α-cyclodextrin to fat in the cream of about 1:20-1:3 w/w,preferably about 1:13-1:5 w/w and more preferably about 1:9 w/w.Reducing the amount of time required for whipped cream to form reducesthe amount of power needed to run a mixer, which when calculated on acommercial scale results in a large monetary savings in both electricityand manpower. The whipped cream remains soft and scoopable and the wheydoes not separate from the rest of the components.

It is envisioned herein that the α-cyclodextrin-containing whipped creammay be used as a topping on another fat containing material that may ormay not contain α-cyclodextrin and the amount of α-cyclodextrin in thewhipped cream would be sufficient to complex the fat in the other fatcontaining material when consumed thus reducing its bioavailability aswell.

EXAMPLES Example 1

FIGS. 9A-9C depict the results of an in vitro study of vegetable oil (4g), water (6 g) (with added food coloring for contrast) and varyingamounts of (A) α-cyclodextrin (100-2,000 mg, right to left), (B)β-cyclodextrin or (C) y-cyclodextrin. A band of “wax-like” materiallayered between the oil and aqueous phases is apparent in the tubes. Thesize of this band increases with increasing amounts of α-cyclodextrin toa maximum in the tube labeled 10% (400 mg α-cyclodextrin/4 g oil). Notethe increasing size (right to left) of a white layer of un-reactedα-cyclodextrin in the bottom of the tubes. This material is displacedfrom solution by either the oil or the α-cyclodextrin-oil complex. Thesetubes were centrifuged in order to improve the definition of the layers.The “wax-like” complex is of such a consistency that all of the tubes in9A except for the furthest two to the right can be inverted withoutleakage of the aqueous phase around the complex.

The pore size of α-cyclodextrin is significantly smaller than the poresize of 0-cyclodextrin and y-cyclodextrin. Thus one would not haveexpected α-cyclodextrin to complex triglyceride molecules because themolecules would not fit within the pore of the α α-cyclodextrin.However, the amount of complexed fat in the tubes containing theoil/β-cyclodextrin (FIG. 9B) and oil/y-cyclodextrin mixture (FIG. 9C) issignificantly less than seen in the tubes containing theoil/α-cyclodextrin mixture (FIG. 9A). This difference is even moredramatic .in FIG. 9C wherein a band of wax-like material is bearlynoticeable. The white substance in the bottom of the tubes isprecipitated cyclodextrin.

Example 2 Animal Studies

To examine the effect of α-cyclodextrin on body weight gain and plasmalipid levels in animals fed high fat and low fat diets, we conducted ashort-term feeding study using Wistar rats. Forty-two male Wistar rats,10 weeks old, were obtained from Harlan-Sprague Dawley. Following aone-week adaptation while being fed the control low fat diet (LF), theywere divided equally into two groups, one low-fat (LF) diet and theother high-fat (HF) diet. These two groups were further divided into twosubgroups. Two groups were fed the LF or HF diet and served as controlsfor the other two test groups which were fed the LF or HF dietcontaining α-cyclodextrin, wherein the amount of α-cyclodextrin was suchthat the ratio of α-cyclodextrin to fat in the food was 1:10 w/w. The LFdiet was formulated according to AIN-93M diet and contains 4% (w/w)soybean oil as the fat source. The HF diet was a modification of the LFdiet with 40% soybean oil. Therefore, the LF group receivingα-cyclodextrin (LF-cyclodextrin) ingested 0.4 g of α-cyclodextrin/0.100g of food and the HF group receiving α-cyclodextrin (HF-cyclodextrin)ate 4 g α-cyclodextrin/100 g of food. The caloric density of the 4 dietswere: LF: 3.96 kcal/g; LF-cyclodextrin: 3.66 kcal/g; HF: 5.70 kcal/g;HF-cyclodextrin: 5.59 kcal/g.

The rats were housed as pairs for five weeks prior to being placed inindividual metabolic cages for the sixth week of the study. All of therats' feces were collected during the final three days of the study. Atthe end of the sixth week of the study period the rats were sacrificedby decapitation after a brief exposure to carbon dioxide gas. Trunkblood and the livers were collected from each animal. The rest of thebody was eviscerated and all visible fat from the internal cavity wascollected and weighed. The carcass was frozen for body compositionanalysis at a later date.

Food and Energy Intake:

The amount of food ingested by the animals was monitored for the firstfive weeks of the study and from these data the caloric intake wascalculated. These data are presented in Table 1 and FIGS. 1 and 2 as anaverage for each group±SD.

TABLE 1 Total food and caloric intake of 4 groups of rats during thefirst 5 weeks of the study (mean ± SD). Group Total Food Ingested (g)Caloric Intake (Kcal) LF 779 ± 40 2,970 ± 154 LF-cyclodextrin 786 ± 872,978 ± 332 HF 753 ± 70 4,072 ± 921 HF-  769 ± 107 3,986 ± 560cyclodextrin

There was no statistical difference amongst any of the groups withregards to the amount (g) of food ingested. Due to the higher caloriccontent of the HF diet, rats in the 2 HF groups consumed significantlymore calories compared to that of the 2 LF fed groups. It should benoted that caloric intake between the two HF groups or the two LF groupswas not affected by the ingestion of α-cyclodextrin. These datademonstrate that (1) all of the rats were satiated by the amount of thefood ingested, and (2) that if the α-cyclodextrin was complexing aportion of the fat and thus preventing the fat from being digested bythe rats, the rats were not consuming more food to compensate for it.There is no statistical difference amongst the groups as it pertains towater consumption.

Body Weight Change:

FIG. 1 illustrates the change in body weight of the four groups ofgrowing rats during the entire study period. As we have previouslydemonstrated (Jen Physiol Behav 42:551-556 (1988) and Jen et al. Int JObesity 19:699-708 (1995) incorporated herein by reference) thoseanimals receiving the HF diet gained more weight than did thosereceiving the LF diet. Interestingly FIG. 3 demonstrates that thoseanimals receiving diet comprising α-cyclodextrin and fat at a ratio of1:10 w/w gained weight at a slower rate relative to their respectivecontrol groups. Although the control group on the HF diet appears tostill be gaining weight at a significant rate, the rate of weight gainof the other three groups appear to have reached a plateau. In thisexample the animals fed the α-cyclodextrin/high fat diet appear to havegained weight at nearly an identical rate as the animals receiving thelow fat diet (4% w/w fat) without α-cyclodextrin. Thus by addingα-cyclodextrin to the diet the animals wherein the amount ofα-cyclodextrin is based on the amount of fat in the diet, in thisexample 4% w/w α-cyclodextrin and 40% w/w fat, the rate of weight gainis significantly inhibited. This is in sharp contrast to previousstudies wherein a cyclodextrin composition was added to rat diets didnot exert an effect on the rate of weight gain until the percentage ofthe cyclodextrin composition in the food was at least 58.5% w/w.

Body Composition:

Body composition analysis reveals that adding α-cyclodextrin to the LFdiet did not affect body fat content. However, when α-cyclodextrin wasadded to the HF diet, it significantly reduced body fat mass (LF:48.3±2.4 g; LF-cyclodextrin: 51±6.5 g; HF: 71.3±5.8 g; HF-cyclodextrin:55.6±2.4 g, mean±SE). This implies that α-cyclodextrin is most effectiveat reducing body fat when the dietary fat is high.

Stoichiometry:

Shimada et al. (Shimada et al. “Structure of inclusion complexes ofcyclodextrins with triglyceride at vegetable oil/water interface” J.Food Sci. 1992; 57(3):655-656) have reported that two molecules ofα-cyclodextrin complex with one free fatty acid (FFA) while Szejtli(Szejtli J. “Utilization of cyclodextrins in industrial products andprocesses” J. Mater. Chem. 1997; 7:575-587) suggests that thisphenomenon is dependent upon the chain length of the fatty acids andthat it is possible for 3-4 molecules of α-cyclodextrin to complex witheach of the three fatty acids of a triglyceride molecule. These resultssuggest 9-12 molecules of α-cyclodextrin would be required to completelycomplex one molecule of triglyceride. If this were the case it would bedifficult to imagine being able to feed enough of the α-cyclodextrin toan animal in order to complex sufficient triglycerides to make asignificant difference in body weight as triglycerides andα-cyclodextrin have similar molecular weights. However, from the datadisclosed herein wherein e.g., a diet comprising 4% α-cyclodextrin and40% fat inhibits weight gain and reduces body fat mass, as the molecularweights are very similar, we have calculated that one α-cyclodextrinmolecule can complex approximately nine molecules of triglyceride, theequivalent of 27 free fatty acids. Thus we can convert this directly to1 gram of α-cyclodextrin complexes approximately 9 grams oftriglyceride. Without wishing to be bound by theory, the difference inthe ratio of α-cyclodextrin molecules needed to complex a triglyceridebased on the disclosure of Shimada or Szejtli and the ratio ofα-cyclodextrin to fat disclosed herein as forming complexes with fatsuggest that, the α-cyclodextrin catalyzes the formation of largeparticles of triglyceride coated with α-cyclodextrin in the form of avery stable micelle, thus reducing the bioavailability of the fats inthose particles. We have been able to demonstrate that when purifiedolive oil is premixed with α-cyclodextrin the lipolytic activity ofporcine pancreatic lipase is significantly reduced. As these particlesare formed in the midst of chyme, a very complex “soup”, the particlesmay be analogous to lipoprotein particles of the blood stream. Thiswould also explain why the bacterial flora do not appear to be able tometabolize the α-cyclodextrin fat complexes coming from the smallintestine.

Fecal Fat Content:

Total lipid determinations were performed on the collected feces usingstandard techniques Folch et al. J Biol. Chem 226: 497-509 (1957)incorporated by reference. The results (FIG. 4) indicate a significantincrease in fecal fat in HF-cyclodextrin (p<0.05) but not inLF-cyclodextrin fed rats. On average this increase was approximately25%. These data indicate that the α-cyclodextrin reduced thebioavailability of the fat by preventing the fat from being absorbedwhen fat intake is high, and, furthermore, prevented it from beingmetabolized by the intestinal flora of the animals' large bowel. Thelatter observation was confirmed by visual inspection of the feces. Allof the collected material appeared to be of normal shape andconsistency; there was no indication of diarrhea.

Plasma Glucose, Cholesterol and Triglyceride Levels:

The plasma glucose, cholesterol and triglyceride concentrations weremeasured on all of the sacrificed animals using standard clinicallaboratory techniques as may be found in Tietz Textbook of ClinicalChemistry, second edition. Burtis C A and Ashwood E R eds., W.B.Saunders Company A Division of Harcourt Brace & Company, 1994,Philadelphia incorporated herein by reference. (FIG. 5). On average theα-cyclodextrin appeared to have decreased the plasma total cholesterollevels by about 10%. This decrease was not statistically significantover this short study period; we expect that with longer feeding period,cholesterol levels will continue to decline. The HDL cholesterol wasalso decreased but by a lesser extent, approximately 6-8%. LDLcholesterol levels on all of the animals were too low to measurereliably since in rats the majority of the cholesterol is carried in theHDL-cholesterol fraction, and very little is carried in theLDL-cholesterol fraction. The triglyceride levels were significantlyreduced (p<0.05) by about 30% in the animals that received theα-cyclodextrin. Glucose levels were not affected significantly by HF orα-cyclodextrin feeding in contrast to the results reported in JapanesePatent application S60-94912 wherein the high levels of cyclodextrins(19.5%, 39%, 58.5% or 78% w/w CD:total food) reduced blood glucosesignificantly.

Insulin Resistance:

Increased insulin resistance, elevated blood triglycerides and reducedHDL cholesterol levels are all the risk factors of Syndrome X.Insulin/glucose ratios as well as triglyceride/HDL ratios werecalculated to provide indications about insulin resistance and risk ofSyndrome X. (Szejtli J. Mater. Chem. 1997; 7:575-587 incorporated hereinby reference). Although, due to the short period of the study, HFfeeding did not significantly induce insulin resistance there did appearto be a trend in that direction. Similarly, the HF-cyclodextrin animalsshowed a trend towards reduced insulin resistance. We expect based onthe human data presented below that when the feeding period islengthened insulin resistance will become significant and thatα-cyclodextrin may significantly reduce the insulin resistance seen inHF fed rats. The reduction in triglyceride/HDL cholesterol ratios byα-cyclodextrin indicated a significant decrease in the risk for SyndromeX.

Leptin:

Leptin is a protein hormone with important effects in regulating bodyweight, metabolism and reproductive function. Leptin is secretedpredominantly by adipocytes, supporting the idea that body weight issensed as the total mass of fat in the body. Thus we analyzed the plasmaleptin levels in the animals fed the LF and HF diets±α-cyclodextrinusing standard techniques.

FIG. 6 compares the plasma leptin values obtained from the four groupsof rats wherein leptin levels were determined by using an RIA rat leptinkit (Limo Research, St. Charles, Mo.) following manufacturersinstructions, incorporated here in by reference. The amount of leptinpresent in the plasma of the HF rats (18.1±3.2 ng/mL) is statisticallyhigher (p<0.001) than that of the LF rats (7.5±1.9 ng/mL). The plasmaleptin concentration of the HF-cyclodextrin rats (9.6±1.8 ng/mL) is notstatistically different from the LF rats. As adipose is the sourcetissue for leptin the data suggests that there is more body fat in theHF rats relative to the other three

To determine the effect of α-cyclodextrin on triglyceride levels, eightvolunteers were fed on two consecutive days a two-egg cheese (54 g)omelet and a milkshake containing a groups. Since leptin reduces foodintake and body weight, the higher levels of leptin indicate a state ofleptin resistance in these HF fed rats. However, when α-cyclodextrin wasadded to the HF diet, rats consuming this diet had significantly lowerleptin levels. This demonstrates that body fat mass was reduced inHF-cyclodextrin rats, and suggests leptin resistance in these rats isreduced. These results suggest that these rats are more sensitive to theeffects of leptin and therefore future weight regain may be moredifficult. When leptin per gram of adipose tissue was calculated, it wasrevealed that both diet fat and α-cyclodextrin had independent effectson blood leptin levels (LF: 0.11±0.02 ng/mL/g of adipose tissue; LF-CD:0.075±0.01; HF: 0.24±0.03; HF-CD: 0.17±0.03; diet effect p<0.001; CDeffect p<0.001). In rats fed the HF diet with added α-cyclodextrin, thereduction in blood leptin level was more than that which can beaccounted for by the reduction of body fat mass. Therefore,α-cyclodextrin reduces blood leptin levels and reduces leptin resistancein addition to that induced by reduced body weight/fat. Similar resultswere obtained in human studies (see Example 4).

Example 3 Initial Clinical Data Effect of α-Cyclodextrin on SerumTriglyceride Levels

To determine the effect of α-cyclodextrin on triglyceride levels, eightvolunteers were fed on two consecutive days a two-egg cheese (54 g)omelet and a milkshake containing a total of 47 g of fat after anovernight fast. On the first day the meal also contained approximately 5g of α-cyclodextrin. Blood samples (10 ml) from each volunteer taken viaan in-dwelling venous catheter immediately prior the meal (zero-time)and at 1, 2 and 3 hours after the meal was consumed and were assayed forserum triglyceride levels. The zero-time sample were used as thebaseline to calculate the percentage change in blood serum triglyceridelevels of the human volunteers at one, two and three hours. FIG. 7illustrates the data collected from the volunteers. It is of note thatthe expected increase in serum triglyceride levels is less when theα-cyclodextrin was mixed with the food than when it is not present,although the difference failed to reach significance (p<0.08) due tolarge variation among the individuals and the small number ofindividuals included in this study.

FIG. 7 also contains data from three of the volunteers who had partakenin an earlier two-hour study with a smaller meal (denoted “*”). Theearlier two hour study also demonstrates that the change in triglyceridelevels is less when α-cyclodextrin is included in the meal.

Weight Loss Effects

To determine if α-cyclodextrin added to a high fat diet resulted inweight loss, α-cylcodextrin was added to the high fat diet of a testsubject, i.e., a 50 year old male human volunteer, five feet seveninches tall with an initial weight of 267 pounds. The α-cyclodextrin wasadded to the subject's diet in a proportion of one gram Ofα-cyclodextrin for every nine grams of fat that were estimated to beconsumed by the subject. FIG. 8 demonstrates the change in the bodyweight of the subject over a period of. 200 days, approximately 6months_By 6 months the subject's body weight was reduced by 32 pounds.In addition to the weight loss, within the first two weeks of the study,the subject's elevated blood pressure fell to the point where he wasforced to reduce his prescribed beta-blacker by one-third. His bloodtriglycerides were also assayed during this time and his blood serumtriglyceride levels were decreased by 23% within the first month and 46%by the end of six months. The effects of the α-cyclodextrin on variousparameters are set forth in Table 2.

TABLE 2 Parameter Baseline 1 month 6 months Cholesterol (mmol/L) 4.764.76 4.0 HDL cholesterol (mmol/L) 0.97 1.00 1.11 Cholesterol/LDL 4.914.76 4.41 Triglycerides (mmol/L) 2.76 2.13 1.50 Insulin Resistance 2.852.13 1.35 Body Mass Index 39.17 37.27 Waist (cm) 124 117 Hip (cm) 127117 Dietary Energy Kcal/d 1,656 1,795 Total Fat (g/d) 112 103 Proportionfat (%) 60.9 51.7 Total Carbohydrate (g/d) 56 84 ProportionCarbohydrates 13.5 18.7 (%) Total Protein (g/d) 106 133 ProportionProtein (%) 25.6 29.6

α-cyclodextrin was also added to the diet of two additional volunteers.The α-cyclodextrin was added in a proportion such that each mealcomprised about 2 g of α-cyclodextrin. Table 3 sets forth the effects ofthe α-cyclodextrin on reducing the levels of cholesterol, LDL,cholesterol/HDL ratio and serum triglycerides. It is of note that bothof these volunteers, as well as the initial volunteer, had been andstill were taking one of the statin pharmaceuticals for lowering theirblood serum cholesterol. All three volunteers were taking differentstatins. In addition volunteer “FK” was taking 3 g/d niacin which hereduced by 50% in the first two weeks of the study because of theunpleasant side effects of this medication.

TABLE 3 Period Volunteer Months Cholesterol Cholesterol/HDL LDL TG FK2.5 −18.5% −16.1% −25.6% −22.2% JA 6 −10.2% −8.8% −15.0 −37.5%

Example 4 Insulin and Leptin Levels

Blood samples were taken from the two additional subjects in Example 3at various timepoints and assayed for insulin levels and leptin levelsby the method of Linco Research (St. Charles, Mo.) using human insulinand leptin radioimmune assays.

The results of this analysis, presented in Table 4, demonstrate that thereduction in levels of insulin and leptin is more than that which can beaccounted for by the reduced body weight.

TABLE 4 Body weight Insulin Leptin Days on diet (lb/kg) (uU/ml) (ng/ml)Subject 1 0 196/89.09 14 3.6 55 188/85.45 13 2.9 112 180/81.82 8 1.6 %decrease 5.0% 42.9% 55.6% Subject 2 0  232/105.45 26 6.1 28  230/104.5528 6.0 62 220.5/100.23  16 3.9 % decrease 5.0% 38.5   36%

Example 5

An eighteen month old, neutered male dog of unknown parentage havingchronic diarrhea was de-wormed twice and placed on hypoallergenic foodin an effort to control the diarrhea. However, the chronic diarrhea wasnot alleviated and the dog stopped eating for a day or two on two orthree separate occasions.

The dog was then treated with α-cyclodextrin as follows: The dog wasplaced on a diet comprising a teaspoon (2.5 g) of α-cyclodextrin mixedwith two cups dry food twice a day for two and one-half weeks. Based onthe fat content in the food, the ratio of α-cyclodextrin to fat wasabout 1:9. The dog's chronic diarrhea was eliminated during this periodexcept for an acute episode of loose stools after a day of swimming in ariver but the stool has been formed ever since.

The dog was then fed an identical diet that did not compriseα-cyclodextrin for 4 days. The dog very quickly lost his appetite, selfrestricted his food intake by about one-half and began eating grass,grass helps to bind his stool. The diarrhea returned.

Example 6 Food Products

The amount of α-cyclodextrin incorporated into the foods of thisinvention is based on the amount of fat contained in the food product.The following describes a variety of conventional fat containing foodsproducts wherein α-cyclodextrin has been added in accordance with thisinvention. Table 5 sets forth the total weight of the food products andthe amounts of α-cyclodextrin, fat and carbohydrates in the productsdescribed in this example compared to products described in otherreferences.

A. Chocolate Chocolate Chip Espresso Cookies

260 g pastry flour 75 g cocoa powder 3.8 g baking powder 2.8 g salt 226g margarine 150 g sugar 180m1 (165 g) molasses or brown sugar 28 gα-cyclodextrin 5 g vanilla extract 22 g espresso (room temperature) 2eggs 115 g chocolate chips

The flour, cocoa, baking powder and salt were mixed together and thenthe margarine, sugar, molasses (or brown sugar), α-cyclodextrin, vanillaand espresso were added to the mixture. Lightly beaten eggs were stirredinto the batter and the chocolate chips were folded in. Largeteaspoon-size dollops of the batter were placed on a lightly greasedcookie sheet and then baked for about 15 minutes in a conventional ovenor 10-12 minutes in a convection oven preheated at −375° F. The cookedcookies were cooled on a wire rack.

Most blinded tasters found that the baked cookies were indistinguishablefrom those prepared from the same recipe without the addition of theα-cyclodextrin. Those who detected a difference preferred those thatincluded the α-cyclodextrin as they were described to be; richer,smoother, tastier and moister with a more pleasing texture in the mouththan the cookies without the α-cyclodextrin.

B. Honey Oatmeal Cookies

42 g butter 110 g brown sugar 85 g honey 1 egg 15 g water 58 g flour 2.5g salt 0.75 g baking soda 81 g rolled oats 4 g α-cyclodextrin

In a mixer, preferably with a paddle attachment, the wet ingredients,butter, brown sugar, honey, egg and water, were mixed together. Theremaining dry ingredients except for the rolled oats, were siftedtogether into a bowl. The rolled oats were then added to the dryingredients. The wet and the dry ingredients were then mixed togetherand aliquots of the batter were deposited onto a greased cookie sheetand baked for 12-15 minutes in a conventional oven preheated to 350° F.or 8-10 minutes in a convection oven. The cooked cookies were cooled ona wire rack.

Most blinded tasters found that the baked cookies were indistinguishablefrom those prepared from the same recipe without the addition of theα-cyclodextrin. Those who detected a difference preferred those thatincluded the α-cyclodextrin as they were described to be; richer,smoother, tastier and moister with a more pleasing texture in the mouththan the cookies without the α-cyclodextrin.

C. Five Layer Bars

69 g corn flake crumbs 100 g sugar 113 g butter or margarine 115 gchocolate chips 115 g butterscotch chips 124 g flaked coconut 63 gchopped nuts 1 can (14 oz, 400 g) sweetened condensed milk 36 gα-cyclodextrin

Corn flake crumbs, sugar, melted butter and 18 g α-cyclodextrin weremixed together in a 13×9×2-inch baking pan, stir together. The mixturewas pressed evenly and firmly in bottom of pan to form a crust.

The chocolate chips, butterscotch chips, coconut, and chopped nuts werespread evenly in layers over the crust and 14 oz (400 g) of sweetenedcondensed milk mixed with 18 g of α-cyclodextrin were poured evenly overthe 5 layers and then baked at 350° F. for 23 minutes or until lightlybrowned around edges. The product was cooled completely and cut into 24pieces.

Most blinded tasters found that the baked bars were indistinguishablefrom those prepared from the same recipe without the addition of theα-cyclodextrin. Those who detected a difference preferred those thatincluded the α-cyclodextrin as they were described to be; richer,smoother, tastier, sweeter and moister with a more pleasing texture inthe mouth than the bars without the α-cyclodextrin. It is of note thatsweetened condensed milk undergoes a significant change upon mixing withα-cyclodextrin. Typically sweetened condensed milk is very thick makingit difficult to pour and is an unappealing off-white color. Upon mixingwith the α-cyclodextrin it becomes much smoother and more fluid innature as well as changing in appearance to a very bright white color.

D. Macaroni with Cheese

98 g butter 29 g flour 484 g half and half cream 4 g salt 0.53 g groundwhite pepper 6 g chili sauce 106 g grated parmesan cheese 57 g gratedcheddar cheese 50 g grated fontina cheese 50 g grated gruyere cheese 450g macaroni 3 g minced garlic 25 g fresh bread crumbs 3 g seasoning 33 gα-cyclodextrin ½ tsp seasoning 33 g α-cyclodextrin

29 g of flour and 33 g of α-cyclodextrin were added to 56 g of butter,melted and cooked for 3 minutes. The half and half was added slowly tothe melted butter and flour mixture and then cooked with frequentstirring until thickened, about 4 to 5 minutes. The mixture was removedfrom the heat and the salt, pepper, hot sauce and half of the gratedparmesan were added to the mixture and stirred until the cheese melted.

The macaroni was cooked in boiling water and the cooked macaroni wascombined with butter and the minced garlic. The cheese mixture was addedto the macaroni. The remaining cheeses were mixed and added to themacaroni mixture, the bread crumbs were layered over the macaroni andcheese and baked for 40 to 45 minutes.

Blinded tasters found that the food prepared with the α-cyclodextrin wascreamier and moister than the same food prepared without theα-cyclodextrin.

TABLE 5 CHO wt/ Total Total Total Added α-CD as % α-CD as % α-CD as % ofKcal fat wt/total Kcal total wt weight, g CHO, g fat, g α-CD, g total wtof CHO fat fat (%) wt (%) CHO (%) (%) Cheese omelet 162 5 30 3.5 2.2% 70% 11.7% 68% 18.5%  5% 3.1% Peanut butter 34 (2 tsp) 8 16 2.0 5.9% 25% 12.5% 70%   47% 15% 23.5% Meatloaf 1659 146 317 36 2.2% 24.7%  11.4% 69% 19.1% 14% 8.8% Macaroni w/4 1586 395 293 33 2.1% 8.4%  11.3%51% 18.5% 31% 24.9% cheeses Five layer bars 1241 702 292 35 2.8% 5.0%  12% 46    23.5    49% 56.6% French-apple 1365 295 112 10.5 0.8% 3.6% 9.4% 42.4%    8.2% 49.6%   21.6% bread pudding Honey oatmeal 492 308 483.5 0.7% 1.1%  7.3% 24%  9.8% 69% 62.6% cookies Chocolate 1020 556 23128 2.8% 5.0% 12.2% 46% 22.7% 49% 54.5% chocolate chip expresso cookiesBiscotti 1323 870 108 12 0.9% 1.4% 11.1% 20%  8.2% 71% 65.8% Butter cake470 170 141 50 (CD 10.6% (CD 29.4% (CD 35.5% (CD 64%   30% 31% 36.2%Japanese comp)² comp)² comp)² comp)² application 3.2% α-CD 8.8% α-CD10.6% α-CD S60-94912 Chinese 1336 535 22.15 300 22.5% (CD 56.1% (CD1364% (CD  7% 1.7% 72% 74.9% noodles (CD comp)² comp)² comp)² (18.8%Japanese comp)² 7.5% α-CD 18.7% α-CD 454% α-CD frying) applicationS60-94912 Biscuit 2015 1400 400 500 (CD 24.8% (CD 35.7% (CD 125% (CD 45%19.9% 49% 69.5% Japanese comp)² comp)² comp)² comp)² application 7.4%α-CD 10.7% α-CD 37.5% α-CD S60-94912 ¹From Best Recipes This Side ofHeaven Holy Trinity Anglican Church Cookbook Committee, Yorkton,Saskatchewan p. 172, Perksen Printers Ltd. Steinbach, Manitoba ROA 2AOCA ²CD comp. = a mixture of cyclodextrins

A clear relationship exists between weight gain, obesity and a varietyof pathologic disorders, e.g., diabetes, insulin resistance,cardiovascular disease, elevated blood lipid levels, sleep apnea,arthritis, certain types of cancer and elevated mortality rates (Solomonand Manson, “Obesity and modality: a review of the epidemiologicaldata”. Am J Clin Nutr 1997; 66:1044 S-1050S). The total health care andlost productivity costs for obesity-related disorders reached $117billion in 2000 (Overweight and obesity: At a glance. Office of theSurgeon General, 2001). Changes in body mass index (BMI) are reported toprecede onset of diabetes (Resnick et al., “Relation of weight gain andweight loss on subsequent diabetes risk in overweight adults” JEpidemiol Community Health 2000; 54:596-602), and for every one kgincrease in body weight the prevalence of diabetes increases by 9%(Mokdad et al. “Diabetes trends in the U.S.: 1990-1998”. Diabetes Care2000; 23:1278-1283). Although type II diabetes is associated with excessbody weight, other metabolic abnormalities observed in obesity maycontribute to the onset of Type II diabetes. Obese individuals tend tobe hyperlipidemic, hyperinsulinemic and insulin resistant, all of whichhave been shown to increase the risk of developing Type II diabetes(Kissebah et al. Health risks of obesity. Med Clin North Am 1989;73:111-138; Kreisberg et al., Insulin secretion in obesity. N Engl J Med1967; 276:314-319, and; Olefsky J. Insulin resistance and insulinaction: an in vitro and in vivo perspective. Diabetes 1981; 30:148-162).Therefore, a reduction in the severity of any of these abnormalitieswill also reduce the risk of developing Type II diabetes. The productsof this invention have organoleptic properties desired by consumers andalso promote weight loss and other health benefits.

1. A consumable food product comprising α-cyclodextrin and fat, whereinsaid food product has a ratio of α-cyclodextrin to fat of 1:20 w/w toabout 1:3 w/w of said food product.
 2. The consumable food product ofclaim 1, comprising at least about 7% to about 80% fat by caloriccontent wherein the food product is a farinaceous food productcomprising less than about 9% w/w total cyclodextrin.
 3. The consumablefood product of claim 1 comprising less than about 6% w/w totalcyclodextrin wherein the food product is a farinaceous food productcomprising less than about 9% w/w total cyclodextrin.
 4. The consumablefood product of claim 1 wherein the food product is cooked wherein thefood product is a farinaceous food product comprising less than about 9%w/w total cyclodextrin.
 5. The consumable food product of claim 1comprising complexes of α-cyclodextrin and fat, wherein said foodproduct is a non-farinaceous food product having a ratio ofα-cyclodextrin to fat of 1:20 w/w to about 1:3 w/w of said food product.6. The consumable food product of claim 5 wherein said non-farinaceousfood product is a dairy, meat or vegetable food product.
 7. Theconsumable food product of claim 6 comprising less than about 9% w/wtotal cyclodextrin.
 8. The consumable food product of claim 5 comprising5% to 50% fat w/w. 9.-17. (canceled)
 18. A method for increasing thelevel of high density lipoprotein (HDL) cholesterol or reducing leptinlevels, insulin levels or insulin resistance in a subject in needthereof comprising administering α-cyclodextrin to a subject in needthereof in an amount sufficient to increase HDL levels or reducingleptin levels, insulin levels or insulin resistance.
 19. The method ofclaim 18 wherein about 165 mg to 11 g of α-cyclodextrin is administeredto said subject with a fat containing meal.
 20. The method of claim 18,wherein said subject consumes about 100 g fat per day.
 21. The method ofclaim 18, wherein α-cyclodextrin is in an amount such that it is in aratio of 1:20 to about 1:3 of fat ingested daily by the subject
 22. Themethod of claim 18, wherein total cholesterol levels are not increasedin said subject.
 23. The method of claim 18, wherein the α-cyclodextrinis administered in a form selected from the group consisting of atablet, powder, capsule, liquid and a confection.
 24. The method ofclaim 18, wherein the α-cyclodextrin is administered to the subject inthe form of the consumable food product comprising α-cyclodextrin andfat wherein the ratio of α-cyclodextrin to fat is about 1:20 w/w to 1:3w/w of said food product.
 25. The method of claim 21 wherein about 500mg to 33 g of α-cyclodextrin is administered to the subject in needthereof daily to increase the level of high density lipoprotein (HDL)26.-34. (canceled)
 35. A method of reducing triglyceride levels in asubject comprising administering to a subject in need thereof an amountof α-cyclodextrin wherein the amount of α-cyclodextrin administered tosaid subject and fat ingested daily by said subject is in a ratio ofabout 1:20 to about 1:3 w/w.
 36. The method of claim 35, wherein theα-cyclodextrin is administered in the form of a tablet, powder, capsule,liquid or confection.
 37. The method of claim 35, wherein theα-cyclodextrin is administered to the subject in the form of theconsumable food product comprising α-cyclodextrin and fat wherein theratio of α-cyclodextrin to fat is about 1:20 w/w to 1:3 w/w of said foodproduct.
 38. The method of claim 35 wherein about 500 mg to 33 g ofα-cyclodextrin is administered to the subject in need thereof daily.39.-61. (canceled)